Shilpi Jain
Associate-1 Regulatory Change Manager I Regulatory CMC Submissions & Publishing | GRS | Pfizer Healthcare
- Role
- Associate-1 Regulatory Change Manager at 화이자
- Location
- Chennai, IN
- LinkedIn followers
- 500 followers
About Shilpi Jain
Knowledgeable about US, CA, and EU market drug approval processes, and well-versed in…
Experience
Associate-1 Regulatory Change Manager
Nov 2023 — Present · Chennai, IN
Managed regulatory processes for IND, NDA, ANDA, and DMF submissions, achieving a 5-day turnaround for high-priority responses.• Oversaw 200+ submissions, collaborating with global stakeholders to ensure successful cross-functional execution.• Published and finalized CMC documents in compliance with agency requirements, utilizing e-submission tools like LIQUENT InSight and Adobe Acrobat.
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