Description
The Regulatory Data Coordinator is responsible for driving key activities within the Pfizer RIM system to enable the assessment and management of new or required changes.
They will review events initiated across the product lifecycle, complete system impact assessments, and create Activities, Regulatory Objectives, Submissions to enable GRS to take necessary actions.
Key responsibilities include:
- Managing RIM events and records, ensuring structures and relationships reflect product market registration and align with master data.
- Interpreting communications and driving actions to update the system and notify stakeholders.
- Reviewing and approving data change requests to ensure compliance with data governance policies.
- Providing training and support to business users on data quality standards and best practices.
- Serving as a source of innovative ideas for future efficiencies and effectiveness.
Typical tasks include collaboration and communication with business units, IT, and stakeholders; generating reports on data quality and requests; and facilitating delivery and approval of regulatory submissions.
As a Senior Associate, the Regulatory Data Coordinator will contribute to moderately complex projects, manage their time to meet targets, apply skills and discipline knowledge, make decisions within guidelines and policies, and participate as a team member.
The ideal candidate has a B.S./B.Scs. in Pharmacy, Life Sciences, Business, or Information Technology, 2+ years of experience in regulatory, data management, or a related role, and E2E global regulatory change management experience.