Vault RIM process and system is highly dependent on accurate & complete metadata at all levels and there is also ?an increasing amount of data that Health Authorities are requiring to be tracked and submitted.? Master data is crucial for regulatory & Pfizer because itensures the accuracy, consistency, and reliability of data used in regulatory submissions and compliance processes.Accurate master data directly impacts the quality, safety, and efficacy of products, and any inconsistencies can lead to delayed approvals, product recalls, and regulatory penalties.The Regulatory Data Steward is accountable for the creation and maintenance of V-RIM Master Data on behalf of the organization. They are specifically responsible & accountable for the creation & maintenance of core/master data inclusive of dentification of Medicinal Products (IDMP) and creation of applications, e.g. for initial registrations. They work in close collaboration with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO and labelling groups to generate and maintain data and form a partnership with Data Coordinators and RIDGE/enterprise-wide Data Governance teams. Note: Role is not accountable for governance or maintenance of dictionary values as designed. The role demands significant experience and understanding of regulatory data, interdependencies within and across Vaults and its implications across the business to ensure product compliance. They support strategy implementation, bridging strategy and execution, and offering crucial insights and feedback at the strategic level. A percentage of the role will be dedicated to harnessing Veeva data and to advance the digital landscape within Global Regulatory Sciences. Due to the broad scope, the position provides growth opportunities in Operations, Strategy, and Digital. JOB RESPONSIBILITIES Generate & Maintain Regulatory & Enterprise Master Data:Accountable for leading the accurate definition & recording of master data in alignment with data standards , driving discussions with strategy partners, BPOs, data owners and operational partners, challenging perspectives where necessary based on their domain expertise. Execute & oversee application/registration creation: Determining when to create new v. use existing objects, system structure of objects needed to enable both accurate representation of the product and management of the product in the system in collaboration with GRS lines?. Responsible forensuring the accuracy, completeness, and consistency of data within theVeeva Vault RIMsystem byverifying and updating data,executing approved change requests,maintaining data quality, andresolving issuesrelated to regulatory information, such as applications, submissions, products, and commitments. This role involves data research, communication with internal and external stakeholders, and adherence to data governance policies to support global regulatory processes. Oversee the portfolio in partnership with Data Coordinators as part of a matrix, product aligned model. Establish subject matter expertise in product data, global license & registrations and active & historical changes. Data model, hierarchy and standards subject matter expert, maintaining a detailed working knowledge of data relationships & dependencies within regulatory and enterprise-wide vaults. Ensure data consistency and accuracy across different systems and platforms, enabling connectivity and establishment and implementation of data management best practices inclusive of single authoritative source data. Conduct regular QC, data audits, identify data issues, and adhere to data quality standards as defined by data governance (DOVE). Lead data remediation projects in alignment within current and emerging global standards. Review and Approve Data Changes:Evaluate and approve data change requests, ensuring compliance with data governance policies. Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum process in support of products through the development and commercial Lifecyle of a drug. Manage and/or support Data Coordinators, clarifying and providing awareness overviews of changed or new processes. Ensure escalations, business process & solution achieves business needs. Evolve service based on strategic objectives efficiency / quality drivers. Provides guidance to and/or may lead/co-lead moderately complex projects. Applies skills and discipline knowledge to contribute to the achievement of work within Department. Has comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding/knowledge of principles and concepts of other disciplines. Able to operate independently in ambiguous situations. May review work completed by other colleagues when acting in mentor role. Individual contributor or takes a formal leadership role of data coordinators alongside their data steward accountabilities. Develops ideas and leads/co-leads complex projects across Sub Business Unit/Sub Operating Unit. Develops and manages plans to achieve objective. Applies skills and domain expertise to contribute to the achievement of work within Sub Business Unit/Sub Operating Unit. Has advanced knowledge of the principles, concepts and theories in the discipline, and comprehensive knowledge of principles and concepts in other disciplines. Makes decisions that require developing innovative options to resolve complex problems. Makes decisions within general business line or functional guide. Leads operational team(s) within and across Work Teams and Departments. QUALIFICATIONS / SKILLS Bachelors or Masters degree in Life Sciences, Regulatory Affairs, Data Management, or related field. Strong experience in Regulatory Affairs or Regulatory Operations with Masters degree, with some experience in a data governance, data management, or data quality role. Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment. Strong understanding of global regulatory submission and compliance requirements. Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs ?and support compliance (e.g., Veeva RIM, Liquent, Lorenz). Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling. Strong understanding of data governance principles and best practices, certification in data management or data governance (e.g., ISO IDMP, xEVMPD, SPL). Experience with master data management and data quality improvement. Aptitude for how data can be leveraged to drive efficiency and innovation. Technical Expertise: Demonstrated knowledge of / experience with strategic business planning and operations. Communications Skills: Ability to communicate complex information and analyses, and difficult messages, to a variety of audiences in both verbal and written format. Business Perspective: Cross functional, Global perspective within the context of business needs and impact. Must have demonstrated business acumen; strong organizational management skills, the ability to handle multiple demands simultaneously; the ability to respond to tight timelines; as well as the capability to interact with all levels of the organization in a professional and discrete manner. Proven ability to influence and lead cross-functional teams without direct authority. Deals with Ambiguity; Creativity; Ability to Adapt in Real-Time. Fluent in English. Emerging people leader with proven experience managing colleagues and/or contractors within a matrix environment. ORGANIZATIONAL RELATIONSHIPS Regulatory Strategy, CMC leads, Clinical, Non-Clinical, Data Coordinators, RIO, Digital. Will work in a highly matrixed environment and in close collaboration with Operations and Strategy. RESOURCES MANAGED Lead Data Coordinators in a matrix or formal reporting relationship. Project specific resources & vendor staff. Work Location Assignment: Hybrid (some office presence is required) Purpose Breakthroughs that change patients' lives At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.Lets start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident . click apply for full job details
08/12/2025
Full time
Vault RIM process and system is highly dependent on accurate & complete metadata at all levels and there is also ?an increasing amount of data that Health Authorities are requiring to be tracked and submitted.? Master data is crucial for regulatory & Pfizer because itensures the accuracy, consistency, and reliability of data used in regulatory submissions and compliance processes.Accurate master data directly impacts the quality, safety, and efficacy of products, and any inconsistencies can lead to delayed approvals, product recalls, and regulatory penalties.The Regulatory Data Steward is accountable for the creation and maintenance of V-RIM Master Data on behalf of the organization. They are specifically responsible & accountable for the creation & maintenance of core/master data inclusive of dentification of Medicinal Products (IDMP) and creation of applications, e.g. for initial registrations. They work in close collaboration with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO and labelling groups to generate and maintain data and form a partnership with Data Coordinators and RIDGE/enterprise-wide Data Governance teams. Note: Role is not accountable for governance or maintenance of dictionary values as designed. The role demands significant experience and understanding of regulatory data, interdependencies within and across Vaults and its implications across the business to ensure product compliance. They support strategy implementation, bridging strategy and execution, and offering crucial insights and feedback at the strategic level. A percentage of the role will be dedicated to harnessing Veeva data and to advance the digital landscape within Global Regulatory Sciences. Due to the broad scope, the position provides growth opportunities in Operations, Strategy, and Digital. JOB RESPONSIBILITIES Generate & Maintain Regulatory & Enterprise Master Data:Accountable for leading the accurate definition & recording of master data in alignment with data standards , driving discussions with strategy partners, BPOs, data owners and operational partners, challenging perspectives where necessary based on their domain expertise. Execute & oversee application/registration creation: Determining when to create new v. use existing objects, system structure of objects needed to enable both accurate representation of the product and management of the product in the system in collaboration with GRS lines?. Responsible forensuring the accuracy, completeness, and consistency of data within theVeeva Vault RIMsystem byverifying and updating data,executing approved change requests,maintaining data quality, andresolving issuesrelated to regulatory information, such as applications, submissions, products, and commitments. This role involves data research, communication with internal and external stakeholders, and adherence to data governance policies to support global regulatory processes. Oversee the portfolio in partnership with Data Coordinators as part of a matrix, product aligned model. Establish subject matter expertise in product data, global license & registrations and active & historical changes. Data model, hierarchy and standards subject matter expert, maintaining a detailed working knowledge of data relationships & dependencies within regulatory and enterprise-wide vaults. Ensure data consistency and accuracy across different systems and platforms, enabling connectivity and establishment and implementation of data management best practices inclusive of single authoritative source data. Conduct regular QC, data audits, identify data issues, and adhere to data quality standards as defined by data governance (DOVE). Lead data remediation projects in alignment within current and emerging global standards. Review and Approve Data Changes:Evaluate and approve data change requests, ensuring compliance with data governance policies. Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum process in support of products through the development and commercial Lifecyle of a drug. Manage and/or support Data Coordinators, clarifying and providing awareness overviews of changed or new processes. Ensure escalations, business process & solution achieves business needs. Evolve service based on strategic objectives efficiency / quality drivers. Provides guidance to and/or may lead/co-lead moderately complex projects. Applies skills and discipline knowledge to contribute to the achievement of work within Department. Has comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding/knowledge of principles and concepts of other disciplines. Able to operate independently in ambiguous situations. May review work completed by other colleagues when acting in mentor role. Individual contributor or takes a formal leadership role of data coordinators alongside their data steward accountabilities. Develops ideas and leads/co-leads complex projects across Sub Business Unit/Sub Operating Unit. Develops and manages plans to achieve objective. Applies skills and domain expertise to contribute to the achievement of work within Sub Business Unit/Sub Operating Unit. Has advanced knowledge of the principles, concepts and theories in the discipline, and comprehensive knowledge of principles and concepts in other disciplines. Makes decisions that require developing innovative options to resolve complex problems. Makes decisions within general business line or functional guide. Leads operational team(s) within and across Work Teams and Departments. QUALIFICATIONS / SKILLS Bachelors or Masters degree in Life Sciences, Regulatory Affairs, Data Management, or related field. Strong experience in Regulatory Affairs or Regulatory Operations with Masters degree, with some experience in a data governance, data management, or data quality role. Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment. Strong understanding of global regulatory submission and compliance requirements. Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs ?and support compliance (e.g., Veeva RIM, Liquent, Lorenz). Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling. Strong understanding of data governance principles and best practices, certification in data management or data governance (e.g., ISO IDMP, xEVMPD, SPL). Experience with master data management and data quality improvement. Aptitude for how data can be leveraged to drive efficiency and innovation. Technical Expertise: Demonstrated knowledge of / experience with strategic business planning and operations. Communications Skills: Ability to communicate complex information and analyses, and difficult messages, to a variety of audiences in both verbal and written format. Business Perspective: Cross functional, Global perspective within the context of business needs and impact. Must have demonstrated business acumen; strong organizational management skills, the ability to handle multiple demands simultaneously; the ability to respond to tight timelines; as well as the capability to interact with all levels of the organization in a professional and discrete manner. Proven ability to influence and lead cross-functional teams without direct authority. Deals with Ambiguity; Creativity; Ability to Adapt in Real-Time. Fluent in English. Emerging people leader with proven experience managing colleagues and/or contractors within a matrix environment. ORGANIZATIONAL RELATIONSHIPS Regulatory Strategy, CMC leads, Clinical, Non-Clinical, Data Coordinators, RIO, Digital. Will work in a highly matrixed environment and in close collaboration with Operations and Strategy. RESOURCES MANAGED Lead Data Coordinators in a matrix or formal reporting relationship. Project specific resources & vendor staff. Work Location Assignment: Hybrid (some office presence is required) Purpose Breakthroughs that change patients' lives At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.Lets start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident . click apply for full job details
Pfizer UK Undergraduate Programme 2026/2027 Digital Transformation Undergraduate Global Regulatory Sciences (GRS) Worldwide Regulatory Operations (GRO) Regulatory Innovation, Data Governance and Excellence (RIDGE) Who can apply? Applicants must be completing a placement as part of a degree course at a UK University, either through Year in Industry/Industrial Placement or Gap Year. Please note that we wil
08/12/2025
Full time
Pfizer UK Undergraduate Programme 2026/2027 Digital Transformation Undergraduate Global Regulatory Sciences (GRS) Worldwide Regulatory Operations (GRO) Regulatory Innovation, Data Governance and Excellence (RIDGE) Who can apply? Applicants must be completing a placement as part of a degree course at a UK University, either through Year in Industry/Industrial Placement or Gap Year. Please note that we wil
Pfizer UK Undergraduate Programme 2026/2027 Digital Transformation Undergraduate Global Regulatory Sciences (GRS) Worldwide Regulatory Operations (GRO) Regulatory Innovation, Data Governance and Excellence (RIDGE) Who can apply? Applicants must be completing a placement as part of a degree course at a UK University, either through Year in Industry/Industrial Placement or Gap Year. Please note that we will only consider candidates who have applied by completing the Pfizer Placement Application Form. Candidates who do not complete and attach the application form will NOT be considered. You can download the Word version of the Application Form here: Undergraduate Vacancies Pfizer UK and find instructions as to how to complete your application and more about eligibility criteria. To learn more about this exciting opportunity, please see below Department Overview The Regulatory Innovation, Data Governance and Excellence (RIDGE) group sits within Pfizers Regulatory International Operations (RIO) under the Global Regulatory Sciences (GRS) division. RIDGE is dedicated to transforming culture, data, processes, and technology through a clear vision, strategy, and roadmap. Its mission is to accelerate digital health, place data at the heart of decision-making and innovation, and prepare for the future by empowering talent, fostering partnership, and celebrating success. Strategic aspects of the function: Innovation and Transformation: Trainees will be part of a team that spearheads strategic initiatives to drive organizational change and foster a culture of innovation. They will have the opportunity to lead projects as well as identify opportunities for improvement, implement transformative projects, and ensure the alignment of business processes with GRS and Pfizers long-term goals. Data-Centric Approach: The RIDGE group advocates for data centricity and uncurated data, identifying opportunities for digital transformations that speed up market access. Trainees will gain experience in developing expertise in data standards and data flow and co-developing underlying architecture to support these initiatives. Cross-Functional Partnership: Trainees will collaborate with cross-functional teams, including Information Management (IM) and Digital, to develop and execute innovative solutions that enhance efficiency, productivity, and competitiveness. This partnership provides a dynamic and stimulating work environment. Professional Development: Trainees will be mentored by experienced professionals and have opportunities to develop their skills in regulatory affairs, project management, and business analysis. They will be involved in defining, monitoring, and leading change projects that support submissions management and improve regulatory operations. What can I achieve and what will I be accountable for whilst completing a placement at Pfizer? Undergraduates will partner closely with the RIDGE team on a range of impactful projects. Four key initiatives currently underway, and continuing into 2025, offer a glimpse into the type of work you could be involved in and the valuable experience youll gain. Transformation Projects: The Veeva RIM project at Pfizer is a transformative initiative designed to revolutionise regulatory information management through Veevas cloud-based software. It aims to streamline processes, improve data accuracy, and enhance overall efficiency. For industrial trainees, this project offers a unique opportunity to gain hands-on experience in change management and communication. Youll work closely with cross-functional teams to support smooth transitions, drive adoption of new processes, and share updates. This dynamic environment provides valuable exposure to regulatory affairs, project management, and digital transformationan excellent platform for professional growth. A Digital Adoption Platform (DAP) is an innovative solution designed to enhance user adoption and optimize the utilization of enterprise applications. By integrating seamlessly with systems like Veeva RIM, a DAP provides automated in-app user guidance through interactive walkthroughs, step-by-step overlays, self-help menus, and contextual information. This not only improves user experience but also increases accuracy and efficiency. For industrial trainees, joining a team working on a DAP project offers the opportunity to be at the forefront of digital transformation, gain hands-on experience with cutting-edge technology, and contribute to projects that drive significant business impact. The "HA Correspondence" project at Pfizer leverages the power of ChatGPT to streamline and enhance the process of handling Health Authority (HA) communications. By integrating ChatGPT, the project aims to automate the generation of responses, ensuring accuracy and consistency while reducing the time required for manual drafting. This innovative approach not only improves efficiency but also allows regulatory professionals to focus on more strategic tasks. For industrial trainees, joining the "HA Correspondence" project offers a unique opportunity to work with cutting-edge AI technology, gain hands-on experience in regulatory affairs, and contribute to a project that has a significant impact on the regulatory landscape. The "Innovation Hub" is an exciting initiative designed to foster creativity and streamline the implementation of innovative ideas within the organization. Established in 2018, the Innovation Hub serves as a central point for employees to submit their ideas or opportunities, which are then reviewed by a dedicated team of project managers and developers. For industrial trainees, this project offers a unique opportunity to gain hands-on experience in project management, working closely with cross-functional teams to bring ideas to life. Trainees will be involved in every stage of the process, from initial idea formulation and business opportunity assessment to solution development and deployment. This dynamic environment not only enhances their project management skills but also provides valuable insights into the business operations and the impact of innovative solutions on the company's success. Other tasks will include: Project Management: Trainees will learn how to define, monitor, and lead change projects, manage timelines, resources, and deliverables, and ensure successful project completion. These skills are essential for managing projects in any industry. Data Governance and Analysis: Trainees will develop expertise in data standards, data flow, and data-centric decision-making. They will learn how to manage and analyse data effectively, which is crucial for roles in data science, analytics, and business intelligence. Cross-Functional Partnership: Working closely with teams from different departments, trainees will enhance their ability to work with and communicate effectively across functions. This skill is important for roles that require teamwork and coordination. Innovation and Change Management: Trainees will be involved in identifying opportunities for improvement and implementing transformative projects. They will gain experience in driving organizational change and fostering a culture of innovation, which is valuable for roles in business development and strategy. When can I start? Placements will start on 1st September 2026 and will run for 12 months. PERSON SPECIFICATION Completing placement as part of University Degree either through Year In Industry/Industrial Placement or Gap Year Influencing: Ability to support and operate seamlessly to influence colleagues across the organization and ensure delivery to time and quality driving highly complex projects to meet evolving business needs Communicator: Excellent verbal and written communication skills to effectively convey ideas and work with colleagues and associates within the organisation, across various cultures. Self-Management: Ability to work freely, prioritise tasks, and manage time efficiently. Problem Solving: Systematic thinking and creativity to identify opportunities and develop effective solutions. Project Management Skills: Experience or interest in managing projects, including planning, executing, and monitoring progress. Transformation and New Technologies: Passion for innovation and a keen interest in learning and applying new technologies. Change Agile: Adaptability and flexibility to thrive in a dynamic environment and embrace change. As a reminder. Who can apply? Applicants must be completing placement as part of a degree course at a UK University, either through Year in Industry/Industrial Placement or Gap Year. This position will close for applications on 4th January 2026. Please note that we only accept application forms. Please do not send over your CV or cover letter as they will not be considered. Please access the Word version of the Application Form here: Undergraduate Vacancies Pfizer UK and find instructions as to how to complete your application and more about eligibility criteria. Purpose Breakthroughs that change patients' lives At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives click apply for full job details
08/12/2025
Full time
Pfizer UK Undergraduate Programme 2026/2027 Digital Transformation Undergraduate Global Regulatory Sciences (GRS) Worldwide Regulatory Operations (GRO) Regulatory Innovation, Data Governance and Excellence (RIDGE) Who can apply? Applicants must be completing a placement as part of a degree course at a UK University, either through Year in Industry/Industrial Placement or Gap Year. Please note that we will only consider candidates who have applied by completing the Pfizer Placement Application Form. Candidates who do not complete and attach the application form will NOT be considered. You can download the Word version of the Application Form here: Undergraduate Vacancies Pfizer UK and find instructions as to how to complete your application and more about eligibility criteria. To learn more about this exciting opportunity, please see below Department Overview The Regulatory Innovation, Data Governance and Excellence (RIDGE) group sits within Pfizers Regulatory International Operations (RIO) under the Global Regulatory Sciences (GRS) division. RIDGE is dedicated to transforming culture, data, processes, and technology through a clear vision, strategy, and roadmap. Its mission is to accelerate digital health, place data at the heart of decision-making and innovation, and prepare for the future by empowering talent, fostering partnership, and celebrating success. Strategic aspects of the function: Innovation and Transformation: Trainees will be part of a team that spearheads strategic initiatives to drive organizational change and foster a culture of innovation. They will have the opportunity to lead projects as well as identify opportunities for improvement, implement transformative projects, and ensure the alignment of business processes with GRS and Pfizers long-term goals. Data-Centric Approach: The RIDGE group advocates for data centricity and uncurated data, identifying opportunities for digital transformations that speed up market access. Trainees will gain experience in developing expertise in data standards and data flow and co-developing underlying architecture to support these initiatives. Cross-Functional Partnership: Trainees will collaborate with cross-functional teams, including Information Management (IM) and Digital, to develop and execute innovative solutions that enhance efficiency, productivity, and competitiveness. This partnership provides a dynamic and stimulating work environment. Professional Development: Trainees will be mentored by experienced professionals and have opportunities to develop their skills in regulatory affairs, project management, and business analysis. They will be involved in defining, monitoring, and leading change projects that support submissions management and improve regulatory operations. What can I achieve and what will I be accountable for whilst completing a placement at Pfizer? Undergraduates will partner closely with the RIDGE team on a range of impactful projects. Four key initiatives currently underway, and continuing into 2025, offer a glimpse into the type of work you could be involved in and the valuable experience youll gain. Transformation Projects: The Veeva RIM project at Pfizer is a transformative initiative designed to revolutionise regulatory information management through Veevas cloud-based software. It aims to streamline processes, improve data accuracy, and enhance overall efficiency. For industrial trainees, this project offers a unique opportunity to gain hands-on experience in change management and communication. Youll work closely with cross-functional teams to support smooth transitions, drive adoption of new processes, and share updates. This dynamic environment provides valuable exposure to regulatory affairs, project management, and digital transformationan excellent platform for professional growth. A Digital Adoption Platform (DAP) is an innovative solution designed to enhance user adoption and optimize the utilization of enterprise applications. By integrating seamlessly with systems like Veeva RIM, a DAP provides automated in-app user guidance through interactive walkthroughs, step-by-step overlays, self-help menus, and contextual information. This not only improves user experience but also increases accuracy and efficiency. For industrial trainees, joining a team working on a DAP project offers the opportunity to be at the forefront of digital transformation, gain hands-on experience with cutting-edge technology, and contribute to projects that drive significant business impact. The "HA Correspondence" project at Pfizer leverages the power of ChatGPT to streamline and enhance the process of handling Health Authority (HA) communications. By integrating ChatGPT, the project aims to automate the generation of responses, ensuring accuracy and consistency while reducing the time required for manual drafting. This innovative approach not only improves efficiency but also allows regulatory professionals to focus on more strategic tasks. For industrial trainees, joining the "HA Correspondence" project offers a unique opportunity to work with cutting-edge AI technology, gain hands-on experience in regulatory affairs, and contribute to a project that has a significant impact on the regulatory landscape. The "Innovation Hub" is an exciting initiative designed to foster creativity and streamline the implementation of innovative ideas within the organization. Established in 2018, the Innovation Hub serves as a central point for employees to submit their ideas or opportunities, which are then reviewed by a dedicated team of project managers and developers. For industrial trainees, this project offers a unique opportunity to gain hands-on experience in project management, working closely with cross-functional teams to bring ideas to life. Trainees will be involved in every stage of the process, from initial idea formulation and business opportunity assessment to solution development and deployment. This dynamic environment not only enhances their project management skills but also provides valuable insights into the business operations and the impact of innovative solutions on the company's success. Other tasks will include: Project Management: Trainees will learn how to define, monitor, and lead change projects, manage timelines, resources, and deliverables, and ensure successful project completion. These skills are essential for managing projects in any industry. Data Governance and Analysis: Trainees will develop expertise in data standards, data flow, and data-centric decision-making. They will learn how to manage and analyse data effectively, which is crucial for roles in data science, analytics, and business intelligence. Cross-Functional Partnership: Working closely with teams from different departments, trainees will enhance their ability to work with and communicate effectively across functions. This skill is important for roles that require teamwork and coordination. Innovation and Change Management: Trainees will be involved in identifying opportunities for improvement and implementing transformative projects. They will gain experience in driving organizational change and fostering a culture of innovation, which is valuable for roles in business development and strategy. When can I start? Placements will start on 1st September 2026 and will run for 12 months. PERSON SPECIFICATION Completing placement as part of University Degree either through Year In Industry/Industrial Placement or Gap Year Influencing: Ability to support and operate seamlessly to influence colleagues across the organization and ensure delivery to time and quality driving highly complex projects to meet evolving business needs Communicator: Excellent verbal and written communication skills to effectively convey ideas and work with colleagues and associates within the organisation, across various cultures. Self-Management: Ability to work freely, prioritise tasks, and manage time efficiently. Problem Solving: Systematic thinking and creativity to identify opportunities and develop effective solutions. Project Management Skills: Experience or interest in managing projects, including planning, executing, and monitoring progress. Transformation and New Technologies: Passion for innovation and a keen interest in learning and applying new technologies. Change Agile: Adaptability and flexibility to thrive in a dynamic environment and embrace change. As a reminder. Who can apply? Applicants must be completing placement as part of a degree course at a UK University, either through Year in Industry/Industrial Placement or Gap Year. This position will close for applications on 4th January 2026. Please note that we only accept application forms. Please do not send over your CV or cover letter as they will not be considered. Please access the Word version of the Application Form here: Undergraduate Vacancies Pfizer UK and find instructions as to how to complete your application and more about eligibility criteria. Purpose Breakthroughs that change patients' lives At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives click apply for full job details
Vault RIM process and system is highly dependent on accurate & complete metadata at all levels and there is also ?an increasing amount of data that Health Authorities are requiring to be tracked and submitted.? Master data is crucial for regulatory & Pfizer because itensures the accuracy, consistency, and reliability of data used in regulatory submissions and compliance processes.Accurate master data directly impacts the quality, safety, and efficacy of products, and any inconsistencies can lead to delayed approvals, product recalls, and regulatory penalties.The Regulatory Data Steward is accountable for the creation and maintenance of V-RIM Master Data on behalf of the organization. They are specifically responsible & accountable for the creation & maintenance of core/master data inclusive of dentification of Medicinal Products (IDMP) and creation of applications, e.g. for initial registrations. They work in close collaboration with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO and labelling groups to generate and maintain data and form a partnership with Data Coordinators and RIDGE/enterprise-wide Data Governance teams. Note: Role is not accountable for governance or maintenance of dictionary values as designed. The role demands significant experience and understanding of regulatory data, interdependencies within and across Vaults and its implications across the business to ensure product compliance. They support strategy implementation, bridging strategy and execution, and offering crucial insights and feedback at the strategic level. A percentage of the role will be dedicated to harnessing Veeva data and to advance the digital landscape within Global Regulatory Sciences. Due to the broad scope, the position provides growth opportunities in Operations, Strategy, and Digital. JOB RESPONSIBILITIES Generate & Maintain Regulatory & Enterprise Master Data:Accountable for leading the accurate definition & recording of master data in alignment with data standards , driving discussions with strategy partners, BPOs, data owners and operational partners, challenging perspectives where necessary based on their domain expertise. Execute & oversee application/registration creation: Determining when to create new v. use existing objects, system structure of objects needed to enable both accurate representation of the product and management of the product in the system in collaboration with GRS lines?. Responsible forensuring the accuracy, completeness, and consistency of data within theVeeva Vault RIMsystem byverifying and updating data,executing approved change requests,maintaining data quality, andresolving issuesrelated to regulatory information, such as applications, submissions, products, and commitments. This role involves data research, communication with internal and external stakeholders, and adherence to data governance policies to support global regulatory processes. Oversee the portfolio in partnership with Data Coordinators as part of a matrix, product aligned model. Establish subject matter expertise in product data, global license & registrations and active & historical changes. Data model, hierarchy and standards subject matter expert, maintaining a detailed working knowledge of data relationships & dependencies within regulatory and enterprise-wide vaults. Ensure data consistency and accuracy across different systems and platforms, enabling connectivity and establishment and implementation of data management best practices inclusive of single authroatativr source data. Conduct regular QC, data audits, identify data issues, and adhere to data quality standards as defined by data governance (DOVE). Lead data remediation projects in alignment within current and emerging global standards. Review and Approve Data Changes:Evaluate and approve data change requests, ensuring compliance with data governance policies. Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum process in support of products through the development and commercial Lifecyle of a drug. Manage and/or support Data Coordinators, clarifying and providing awareness overviews of changed or new processes. Ensure escalations, business process & solution achieves business needs. Evolve service based on strategic objectives efficiency / quality drivers Individual contributor, working within a matrix environment alongside data coordinators. Provides guidance to and/or may lead/co-lead moderately complex projects. Applies skills and discipline knowledge to contribute to the achievement of work within Department. Has comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding/knowledge of principles and concepts of other disciplines. Able to operate independently in ambiguous situations. May review work completed by other colleagues when acting in mentor role. QUALIFICATIONS / SKILLS Bachelors or Masters degree in Life Sciences, Regulatory Affairs, Data Management, or related field. Some experience in Regulatory Affairs or Regulatory Operations with Masters Degree in a data governance, data management, or data quality role. Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment. Strong understanding of global regulatory submission and compliance requirements. Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs ?and support compliance (e.g., Veeva RIM, Liquent, Lorenz). Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling. Strong understanding of data governance principles and best practices, certification in data management or data governance (e.g., ISO IDMP, xEVMPD, SPL). Experience with master data management and data quality improvement. Aptitude for how data can be leveraged to drive efficiency and innovation. Technical Expertise: Demonstrated knowledge of / experience with strategic business planning and operations. Communications Skills: Ability to communicate complex information and analyses, and difficult messages, to a variety of audiences in both verbal and written format. Business Perspective: Cross functional, Global perspective within the context of business needs and impact. Must have demonstrated business acumen; strong organizational management skills, the ability to handle multiple demands simultaneously; the ability to respond to tight timelines; as well as the capability to interact with all levels of the organization in a professional and discrete manner. Proven ability to influence and lead cross-functional teams without direct authority. Deals with Ambiguity; Creativity; Ability to Adapt in Real-Time. Fluent in English. ORGANIZATIONAL RELATIONSHIPS Regulatory Strategy, CMC leads, Clinical, Non-Clinical, Data Coordinators, RIO, Digital. Will work in a highly matrixed environment and in close collaboration with Operations and Strategy. RESOURCES MANAGED Lead Data Coordinators in a matrix or formal reporting relationship. Project specific resources & vendor staff. Work Location Assignment: Hybrid (some office presence is required) Purpose Breakthroughs that change patients' lives At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.Lets start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! Regulatory Affairs JBRP1_UKTJ
08/12/2025
Full time
Vault RIM process and system is highly dependent on accurate & complete metadata at all levels and there is also ?an increasing amount of data that Health Authorities are requiring to be tracked and submitted.? Master data is crucial for regulatory & Pfizer because itensures the accuracy, consistency, and reliability of data used in regulatory submissions and compliance processes.Accurate master data directly impacts the quality, safety, and efficacy of products, and any inconsistencies can lead to delayed approvals, product recalls, and regulatory penalties.The Regulatory Data Steward is accountable for the creation and maintenance of V-RIM Master Data on behalf of the organization. They are specifically responsible & accountable for the creation & maintenance of core/master data inclusive of dentification of Medicinal Products (IDMP) and creation of applications, e.g. for initial registrations. They work in close collaboration with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO and labelling groups to generate and maintain data and form a partnership with Data Coordinators and RIDGE/enterprise-wide Data Governance teams. Note: Role is not accountable for governance or maintenance of dictionary values as designed. The role demands significant experience and understanding of regulatory data, interdependencies within and across Vaults and its implications across the business to ensure product compliance. They support strategy implementation, bridging strategy and execution, and offering crucial insights and feedback at the strategic level. A percentage of the role will be dedicated to harnessing Veeva data and to advance the digital landscape within Global Regulatory Sciences. Due to the broad scope, the position provides growth opportunities in Operations, Strategy, and Digital. JOB RESPONSIBILITIES Generate & Maintain Regulatory & Enterprise Master Data:Accountable for leading the accurate definition & recording of master data in alignment with data standards , driving discussions with strategy partners, BPOs, data owners and operational partners, challenging perspectives where necessary based on their domain expertise. Execute & oversee application/registration creation: Determining when to create new v. use existing objects, system structure of objects needed to enable both accurate representation of the product and management of the product in the system in collaboration with GRS lines?. Responsible forensuring the accuracy, completeness, and consistency of data within theVeeva Vault RIMsystem byverifying and updating data,executing approved change requests,maintaining data quality, andresolving issuesrelated to regulatory information, such as applications, submissions, products, and commitments. This role involves data research, communication with internal and external stakeholders, and adherence to data governance policies to support global regulatory processes. Oversee the portfolio in partnership with Data Coordinators as part of a matrix, product aligned model. Establish subject matter expertise in product data, global license & registrations and active & historical changes. Data model, hierarchy and standards subject matter expert, maintaining a detailed working knowledge of data relationships & dependencies within regulatory and enterprise-wide vaults. Ensure data consistency and accuracy across different systems and platforms, enabling connectivity and establishment and implementation of data management best practices inclusive of single authroatativr source data. Conduct regular QC, data audits, identify data issues, and adhere to data quality standards as defined by data governance (DOVE). Lead data remediation projects in alignment within current and emerging global standards. Review and Approve Data Changes:Evaluate and approve data change requests, ensuring compliance with data governance policies. Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimum process in support of products through the development and commercial Lifecyle of a drug. Manage and/or support Data Coordinators, clarifying and providing awareness overviews of changed or new processes. Ensure escalations, business process & solution achieves business needs. Evolve service based on strategic objectives efficiency / quality drivers Individual contributor, working within a matrix environment alongside data coordinators. Provides guidance to and/or may lead/co-lead moderately complex projects. Applies skills and discipline knowledge to contribute to the achievement of work within Department. Has comprehensive knowledge of the principles, concepts and theories of the discipline, and good understanding/knowledge of principles and concepts of other disciplines. Able to operate independently in ambiguous situations. May review work completed by other colleagues when acting in mentor role. QUALIFICATIONS / SKILLS Bachelors or Masters degree in Life Sciences, Regulatory Affairs, Data Management, or related field. Some experience in Regulatory Affairs or Regulatory Operations with Masters Degree in a data governance, data management, or data quality role. Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment. Strong understanding of global regulatory submission and compliance requirements. Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs ?and support compliance (e.g., Veeva RIM, Liquent, Lorenz). Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling. Strong understanding of data governance principles and best practices, certification in data management or data governance (e.g., ISO IDMP, xEVMPD, SPL). Experience with master data management and data quality improvement. Aptitude for how data can be leveraged to drive efficiency and innovation. Technical Expertise: Demonstrated knowledge of / experience with strategic business planning and operations. Communications Skills: Ability to communicate complex information and analyses, and difficult messages, to a variety of audiences in both verbal and written format. Business Perspective: Cross functional, Global perspective within the context of business needs and impact. Must have demonstrated business acumen; strong organizational management skills, the ability to handle multiple demands simultaneously; the ability to respond to tight timelines; as well as the capability to interact with all levels of the organization in a professional and discrete manner. Proven ability to influence and lead cross-functional teams without direct authority. Deals with Ambiguity; Creativity; Ability to Adapt in Real-Time. Fluent in English. ORGANIZATIONAL RELATIONSHIPS Regulatory Strategy, CMC leads, Clinical, Non-Clinical, Data Coordinators, RIO, Digital. Will work in a highly matrixed environment and in close collaboration with Operations and Strategy. RESOURCES MANAGED Lead Data Coordinators in a matrix or formal reporting relationship. Project specific resources & vendor staff. Work Location Assignment: Hybrid (some office presence is required) Purpose Breakthroughs that change patients' lives At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.Lets start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! Regulatory Affairs JBRP1_UKTJ
ROLE SUMMARY The Global Information Security (GIS) organization delivers proactive cyber defense for the global Pfizer enterprise. Our mission is to secure all of Pfizer's information assets ranging from the manufacturing floor to the core data centers and out to the patient facing solutions. We achieve this mission through a team of world-class talent, utilizing top-tier technologies, advanced analytics, and the promotion of a cybersecurity ownership culture across the company. The Cyber Threat Intelligence team works with internal and external partners to reduce risk to Pfizer. The team provides timely situational awareness, conducts in depth analysis of threats, and translates indicators of threat into actionable information to reduce impact to Pfizer. Stakeholders include cybersecurity response teams, internal lines of business, senior leadership, external organizations such as law enforcement, and industry peers and intelligence sharing partners. The Senior Cyber Intelligence Analyst is responsible for conducting in-depth research, documentation, and intelligence analysis of key cyber threats, including threat actor tactics, techniques, and procedures (TTPs), to develop a comprehensive picture of the cyber threat landscape, improve Pfizer's security posture, and reduce risk. This individual will provide domain expertise to aid in the effective prioritization and analysis of threats in line with the needs of our stakeholders. The individual will have experience successfully executing all phases of the intelligence lifecycle in support of driving an intelligence led security organization. An ideal candidate for this role will have technical, communication, and interpersonal skills with previous experience mentoring peer CTI analysts and leading CTI initiatives. The position is an individual contributor role that will engage with cross functional internal colleagues and external partners and reports to the Director, Global Threat Research within the Pfizer Digital Global Information Security organization. ROLE RESPONSIBILITIES Perform intelligence analysis of cyber threat activity through execution of the threat intelligence lifecycle. Conduct in-depth intrusion analysis of cyber threats utilizing frameworks such as the Lockheed Martin Cyber Kill Chain, Diamond Model and MITRE ATT&CK. Develop strategic, tactical, and operational intelligence products for stakeholder dissemination in support of priority intelligence requirements. Curate threat intelligence related to the cyber threat landscape such as threat actors, malware, vulnerabilities and tactics, techniques, and procedures. Present cyber threat intelligence to stakeholders that helps drive both tactical and strategic priorities. Participate in and lead team projects centered around the cyber threat intelligence mission. Mentor peer CTI analysts through on the job training opportunities. Interface with external sharing communities through the sharing of timely and relevant cyber threats. QUALIFICATIONS BS in Information Security, Computer Sciences, Information Systems, Engineering, or equivalent with demonstrable professional experience in a corporate environment. Experience in understanding the techniques of Computer Network Exploitation and Defense (CNE / CND). Experience using frameworks such as the Lockheed Martin Cyber Kill Chain, Diamond Model and MITRE ATT&CK. Experience in information analysis and execution of the intelligence lifecycle. Experience developing and curating intelligence related to the cyber threat landscape such as threat actors, malware, vulnerabilities and tactics, techniques, and procedures. Experience with translating threat intelligence from OSINT and private intelligence reports into custom detections and mitigations across multiple security technologies. Experience performing technical indicator and TTP analysis using both open and closed source intelligence sources Ability to provide concise and accurate communications (both verbal and written) in disseminated intelligence products. Ability to communicate and establish rapport with a global team of incident responders and intelligence analysts. Experience mentoring peer analysts in all stages of the intelligence lifecycle. Work Location Assignment: Flexible
19/08/2023
Full time
ROLE SUMMARY The Global Information Security (GIS) organization delivers proactive cyber defense for the global Pfizer enterprise. Our mission is to secure all of Pfizer's information assets ranging from the manufacturing floor to the core data centers and out to the patient facing solutions. We achieve this mission through a team of world-class talent, utilizing top-tier technologies, advanced analytics, and the promotion of a cybersecurity ownership culture across the company. The Cyber Threat Intelligence team works with internal and external partners to reduce risk to Pfizer. The team provides timely situational awareness, conducts in depth analysis of threats, and translates indicators of threat into actionable information to reduce impact to Pfizer. Stakeholders include cybersecurity response teams, internal lines of business, senior leadership, external organizations such as law enforcement, and industry peers and intelligence sharing partners. The Senior Cyber Intelligence Analyst is responsible for conducting in-depth research, documentation, and intelligence analysis of key cyber threats, including threat actor tactics, techniques, and procedures (TTPs), to develop a comprehensive picture of the cyber threat landscape, improve Pfizer's security posture, and reduce risk. This individual will provide domain expertise to aid in the effective prioritization and analysis of threats in line with the needs of our stakeholders. The individual will have experience successfully executing all phases of the intelligence lifecycle in support of driving an intelligence led security organization. An ideal candidate for this role will have technical, communication, and interpersonal skills with previous experience mentoring peer CTI analysts and leading CTI initiatives. The position is an individual contributor role that will engage with cross functional internal colleagues and external partners and reports to the Director, Global Threat Research within the Pfizer Digital Global Information Security organization. ROLE RESPONSIBILITIES Perform intelligence analysis of cyber threat activity through execution of the threat intelligence lifecycle. Conduct in-depth intrusion analysis of cyber threats utilizing frameworks such as the Lockheed Martin Cyber Kill Chain, Diamond Model and MITRE ATT&CK. Develop strategic, tactical, and operational intelligence products for stakeholder dissemination in support of priority intelligence requirements. Curate threat intelligence related to the cyber threat landscape such as threat actors, malware, vulnerabilities and tactics, techniques, and procedures. Present cyber threat intelligence to stakeholders that helps drive both tactical and strategic priorities. Participate in and lead team projects centered around the cyber threat intelligence mission. Mentor peer CTI analysts through on the job training opportunities. Interface with external sharing communities through the sharing of timely and relevant cyber threats. QUALIFICATIONS BS in Information Security, Computer Sciences, Information Systems, Engineering, or equivalent with demonstrable professional experience in a corporate environment. Experience in understanding the techniques of Computer Network Exploitation and Defense (CNE / CND). Experience using frameworks such as the Lockheed Martin Cyber Kill Chain, Diamond Model and MITRE ATT&CK. Experience in information analysis and execution of the intelligence lifecycle. Experience developing and curating intelligence related to the cyber threat landscape such as threat actors, malware, vulnerabilities and tactics, techniques, and procedures. Experience with translating threat intelligence from OSINT and private intelligence reports into custom detections and mitigations across multiple security technologies. Experience performing technical indicator and TTP analysis using both open and closed source intelligence sources Ability to provide concise and accurate communications (both verbal and written) in disseminated intelligence products. Ability to communicate and establish rapport with a global team of incident responders and intelligence analysts. Experience mentoring peer analysts in all stages of the intelligence lifecycle. Work Location Assignment: Flexible