Associate II Reg Strategy, GRS Oncology
Pfizer · Chennai, India +2 more
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Role summary
Pfizer seeks an Associate II in Regulatory Strategy for its Global Regulatory Strategic (GRS) Oncology team. The role involves coordinating lifecycle maintenance submissions, preparing CMC documentation, and supporting health authority interactions across assigned regions while collaborating with global regulatory and cross-functional teams.
What they're looking for
- Bachelor's or Master's degree in pharmacy, life sciences, chemistry, biotechnology, or related field
- 2-4 years of pharmaceutical industry regulatory experience
- Working knowledge of pharmaceutical regulatory submissions and product lifecycle management
- Experience preparing, coordinating, or reviewing regulatory submission documents
- Ability to manage multiple priorities in global matrix environment with strong attention to detail
- Excellent written and verbal communication skills for technical and scientific audiences
- Strategic mindset with critical thinking and data-driven assessment capabilities
What you'll be doing
- Coordinate lifecycle activities including variations, supplements, amendments, renewals, and post-approval commitments for assigned regions
- Author, quality-check, and submit electronic applications, cover letters, and CMC submission packages
- Prepare and coordinate submission components; support health authority question responses and document consistency
- Lead regulatory activities related to labeling updates, safety reporting, and aggregate report tracking
- Collaborate with global, regional, and country teams on submission requirements and implementation
Key requirements
- Therapeutic area
- Oncology
Privacy & handoff
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