Amol Patil
Manager, Regulatory Affairs
- Role
- Manager Global Regulatory Affairs Cmc at 화이자
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Amol Patil
LCM (Life Cycle Management) activities (Post Approval Variations (quality/safety), Supplements and Annual Reports) for Global markets including US, EU and all other emerging markets- Pre-approval (Initial) & Post-approval (LCM) Submissions along with related activities such as controlled correspondences, briefing packages- US (ANDA, 505b(2)) Submissions and ANDA amendments for various dosage forms such as Oral Solids, Sterile Injectables, Ophthalmic, Dermatological, Inhalations dosage forms- Handled ANDA submissions for complex dosage forms such as MDI’s, DPI’s & Ophthalmic suspensions.
Experience
Manager Global Regulatory Affairs Cmc
Apr 2023 — Present
Education
NDMVP College of Pharmacy
M.Pharm, Pharmaceutics and Drug Design
2010 — 2012
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