Regulatory Data Manager
Pfizer · San Jose
Description du poste
About the role
The Regulatory Data Manager will drive critical activities within Pfizer's RIM system, ensuring accurate metadata and supporting regulatory change management across product lifecycles.
Key responsibilities
- Manage all RIM events and related records, maintaining alignment with master data standards and health authority decisions.
- Interpret health authority communications, update systems, and notify stakeholders.
- Review and approve data change requests, ensuring compliance with governance policies.
- Maintain active dossiers throughout product lifecycles, guaranteeing accuracy and completeness.
- Lead or co‑lead moderately complex projects, forecasting resource needs and delivering high‑quality work.
Required profile
- Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management or related field.
- 4+ years of regulatory affairs or operations experience, with at least 3 years in data governance or quality.
- Strong understanding of regulatory system structures, IDMP, CMC, and labeling processes.
- Proven ability to communicate, collaborate and train business users on data standards.
Required skills
- Master data management
- Data governance principles
- Data quality improvement
- Regulatory change impact assessment
- Technical aptitude for new software and regulatory tools
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Pfizer
San Jose