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 the Pfizer RIM system 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 licences & master data as well as the end-to-end regulatory change management experience within & across domains.
Job responsibilities:
- Manage all RIM events and related records, including event and registration details, ensuring structures and relationships accurately reflect product market registrations, align with master data standards, and remain updated in accordance with health authority decisions.
- Interpret health authority communications, drive appropriate system updates, notify stakeholders as needed, and collaborate with GRS stakeholders, CMC strategists, PGS, and cross-functional teams to understand and fulfill data requirements.
- Review and approve data change requests, ensuring compliance with data governance standards, policies, and regulatory requirements.
- Maintain active dossiers throughout the product lifecycle, ensuring ongoing accuracy, completeness, and alignment with health authority decisions.
- Train and support business users on data quality standards, data management practices, and process management best practices.
- Identify and implement innovative solutions that improve efficiency and effectiveness while developing and optimizing processes that support products throughout the drug development and commercial lifecycle.
- Ensure escalations, business processes, and system solutions effectively meet business requirements and stakeholder needs.
- Drive continuous service improvement by aligning processes, solutions, and capabilities with strategic objectives related to efficiency, quality, and operational excellence.
Typical Tasks:
- Collaborate with business units, IT, and other stakeholders to understand data requirements, support data-related initiatives, lead data review/update meetings, and provide guidance to system users through advanced system knowledge.
- Ensure timely notifications are sent to relevant stakeholders following data updates and generate reports on data quality, data requests, and other key metrics.
- Review event information to understand the event's purpose and scope, interpret change items, and ensure appropriate event details are updated to support impact assessments and GPC structure creation.
- Create event details using the designated wizard, selecting appropriate actions and fields.
- Generate impact assessment reports to identify affected registrations.
- Create, verify, and validate activities and related records based on impact assessment reports, ensuring data accuracy, completeness, and proper linkage.
- Facilitate the delivery and approval of Pfizer electronic and paper regulatory submissions through the coordination and execution of CMC components in accordance with submission and national market requirements.
- Manage submission status and deliverables, identify risks, and partner with regulatory strategists and stakeholders to mitigate risks while maintaining accurate metadata in regulatory workflow and document management systems.
- Lead or co-lead moderately complex projects and provide guidance to project teams.
- Manage priorities, meet objectives, and forecast and plan resource requirements, including people, financial, and technology resources, across projects.
- Apply discipline expertise and technical skills to support departmental objectives and deliver high-quality work.
- Analyze moderately complex issues and develop effective solutions to address business challenges.
- Make decisions in non-standard situations while adhering to established policies and procedures.
- Facilitate team discussions, build consensus, and drive progress toward work team goals through informal leadership.
- Serve as a subject matter expert in regulatory processes, systems, and procedures while collaborating across matrixed teams and stakeholders.
- Represent the RIO function and contribute to RIO, GI&PE, and GRS continuous improvement initiatives and projects.
Qualifications and skills:
- Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field
- 4+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3 years in a data governance, data management, or data quality role.
- Product lead/support experience, including management of product/registration information in systems
- 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.
Available to apply until: October 29th EOD.
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
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Regulatory Affairs