Pujitha Raja
Pfizer - Regulatory Affairs | PhD - University of Edinburgh | BITS-Pilani | Anna University | Lifesciences Consulting
- Role
- Associate Manager i at 화이자
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Pujitha Raja
With over 2.5 years as Associate Manager I at Pfizer, I specialise in regulatory affairs,…
Experience
Associate Manager i
Oct 2023 — Present · Chennai, IN
As Associate Manager I (Regulatory Affairs) at Pfizer, I deliver high-quality regulatory strategies for the Oncology portfolio, collaborating with cross-functional teams to expedite global product approvals.1. Prepare, compile, and review regulatory dossiers for the Oncology portfolio in collaboration with regulatory strategists, ensuring compliance with global health authority requirements.2. Coordinate with internal cross-functional teams—including Manufacturing, Quality, and Medical Affairs—to gather and verify data for Chemistry, Manufacturing, and Controls (CMC) submissions.3. Support timely regulatory submissions to multiple global markets, contributing to efficient product approvals and market access.4. Maintain regulatory documentation in accordance with company SOPs and evolving international guidelines.5. Assist in addressing health authority queries and supporting submission-related risk mitigation strategies.
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