Job summary:
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.
- 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 Lifecyle 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.
- Facilitates 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, identifies risks and partners 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)
Senior Associate:
- Contributes to the completion of moderately complex projects
- Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team
- Applies skills and discipline knowledge to contribute to the achievement of work within Work Team
- Makes decisions to resolve moderately complex problems in standard situations
- Makes decisions within guidelines and policies
- Participates and contributes as a team member
Qualifications:
- B.S./B.Scs. is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
- 2+ years of experience in regulatory, data management, data governance, or a related role within the pharmaceutical or healthcare industry.
- 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.
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