Regulatory Data Coordinator, Sr. Manager

Pfizer; Alcester; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Data Coordinator in Alcester, United Kingdom. The role involves managing regulatory events, ensuring compliance with data governance policies, and providing training to users. Candidates should have a degree in Life Sciences or related fields and significant experience in Regulatory Affairs or Data Management. The position requires strong communication skills and attention to detail. This hybrid role offers an opportunity to contribute to innovative projects within a patient-centric culture.

Benefits

Flexible workplace culture

Diversity and inclusion initiatives

Employee support programs

Qualifications

• Strong experience in Regulatory Affairs or Regulatory Operations, including data governance.
• Significant experience with master data management and data quality improvement.
• E2E global regulatory change management experience.

Responsibilities

• Manage all related RIM events and records effectively.
• Evaluate and approve data change requests for compliance.
• Train and support users on data quality standards and procedures.

Skills

Strong communication skills

Collaboration

Attention to detail

Education

Bachelor’s or Master’s degree in Life Sciences

Job description

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.

The Regulatory Data Coordinator is responsible for driving key & critical activities within V‑RIM in support of enabling the assessment and subsequent management of new or required changes (system events).

They will specifically review all events initiated across the product lifecycle, completing system impact assessments, and creating Activities, Regulatory Objectives, Submissions to enable GRS to take the necessary actions. The Coordinator also ensures that Event Details, Change Items & Label Concepts are associated and have the appropriate details as well as creating the Global Content Plan in readiness for content authoring across the enterprise.

The Coordinator will work with the CMC Product strategist(s), labeling leads, Clinical & Country Regulatory Strategists through a mix of strategic and operational support, demanding a detailed understanding of regulatory system structures, product licenses & master data as well as the end‑to‑end regulatory change management experience within & across domains.

JOB RESPONSIBILITIES

• Management of all related RIM events and their related records, including event details and registered details – ensuring structures and relationships enable accurate reflection of the product market registration while still aligning to master data, and ensuring maintenance in alignment with agency decisions.
• HA Decision/Interaction management: Interpreting communications and drive appropriate actions to update system (and potentially notify stakeholders even if accountability for that remains with the Reg Strategist), collaborating with Stakeholders across GRS & CMC strategists, PGS, and other teams to understand data requirements and ensure data needs are met.
• Review and Approve Data Changes: Evaluate and approve data change requests, ensuring compliance with data governance policies.
• Active Dossier Management: Ensuring maintenance across the lifecycle, including in alignment with agency decisions.
• Provide Training and Support: Train & support business users on data quality standards and data & process management best practices.
• 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 lifecycle of a drug.
• Ensure escalations, business process & solution achieves business needs.
• Evolve service based on strategic objectives – efficiency / quality drivers.

TYPICAL TASKS

• Collaboration and Communication: Work closely with business units, IT, and other stakeholders to understand data requirements and support data‑related initiatives. Lead data review/update meetings. Provide guidance and support to system users through an advanced understanding.
• Notifications and Reporting: Ensure that notifications are sent to relevant stakeholders upon completion of data updates. Generate reports on data quality, data requests, and other relevant metrics.
• Review Event Information: Ensure understanding of the event's purpose and scope. Interpret and understand the change items to ensure appropriate event details are updated to enable proper impact assessments and GPC structure to be created.
• Create Event Details: Use the wizard to create event details, selecting appropriate actions and fields.
• Run Impact Assessment Report: Generate the report to identify impacted registrations.
• Create Related Records: Use the wizard to create activities and other related records based on the impact assessment report. Verify the records created by the wizard and confirm their accuracy. Check for any discrepancies and ensure all data is correctly entered and linked.
• Facilitate delivery and approval of Pfizer electronic and paper regulatory submissions through co‑ordination and execution of CMC components to unique requirements and standards of each submission and national market.
• Through active management of status and expected deliverables, identify risks and partner with regulatory strategists and relevant stakeholders to mitigate risks to quality and timeliness of CMC changes while ensuring status is accurately reflected at all times through maintenance of metadata in regulatory workflow and/or document management system(s).
• Contribute to the completion of moderately complex projects.
• Manage own time to meet agreed targets; develop plans for short‑term work activities on own projects (timelines, work plans, deliverables) within a Work Team.
• Apply skills and discipline knowledge to contribute to the achievement of work within Work Team.
• Make decisions to resolve moderately complex problems in standard situations.
• Make decisions within guidelines and policies.
• Participate and contribute as a team member.
• Provide guidance to and/or may lead/co‑lead moderately complex projects.
• Manage own time to meet objectives; forecast and plan resource requirements (people, financial and technology) for projects across Department.
• Apply skills and discipline knowledge to contribute to the achievement of work within Department.
• Make decisions that may require developing new options to resolve moderately complex problems.
• Make decisions guided by policies in non‑standard situations.
• Regularly take informal leadership role during Work Team meetings to facilitate agreements and move the Work Team toward its goals.
• Act as a subject matter expert with extensive regulatory, system & process expertise working in close matrix collaboration with strategists and other local and above country cross‑functional stakeholders.
• Represent the RIO function and play key roles in RIO, GI&PE and GRS improvement projects.
• Develop ideas and lead/co‑lead complex projects across RIO, G&IPE & GRS.
• Develop and manage plans to achieve objectives.
• Apply skills and discipline knowledge to contribute to the achievement of work within Sub Business Unit/Sub Operating Unit.
• Make decisions that require developing innovative options to resolve complex problems.
• Make decisions within general business line or functional guide.
• Lead operational team(s) within and across Work Teams and Departments.
• Involve in visible and timebound complex and/or high volume projects with pan regional impact with challenging constraints.

QUALIFICATIONS / SKILLS

• Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.
• Strong experience in Regulatory Affairs or Regulatory Operations, with some experience in a data governance, data management, or data quality role.
• Significant experience with master data management and data quality improvement.
• E2E global regulatory change management experience, including change initiation, performing impact assessments, submission to HA and management of HA decisions/queries/interactions/commitments.
• Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs and support compliance.
• Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling.
• Detailed understanding of GRS roles/responsibilities related to dossier maintenance and submissions.
• Strong understanding of data governance principles and best practices.
• Experience with master data management and data quality improvement.
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
• Strong communication and collaboration skills.
• Attention to detail and commitment to data accuracy and integrity.
• Product lead/support experience, including management of product/registration information in systems.

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.

Work Location Assignment: Hybrid (some office presence is required)

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient‑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. Let’s 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!