Atul Shinde
Regulatory Associate I - US market | Teva pharmaceuticals.
- Role
- Regulatory Affairs Associate i at Teva Pharmaceuticals
- Location
- Thane, IN
- LinkedIn followers
- 500 followers
About Atul Shinde
Having experience in Regulatory affairs, US post approval changes submission and product…
Experience
Regulatory Affairs Associate i
Apr 2023 — Present · Navi Mumbai, IN
Responsible for Post approval submissions for US-Market for all dosage form (OSD, Parenterals, Topical, oral liquid, cosmetic etc). Preparation, review and compilation of Active and Inactive Annual report as per US-FDA requirements. Preparation, review and submission of post approval supplement such as CBE-0, CBE-30 & PAS. Preparation, review and submission of general correspondence and product withdrawals, REMS Correspondence. Evaluation of change to the process/parameters. Well knowledge of US-FDA guidelines such as SUPAC, ANNUAL REPORTS etc.
Education
University of Mumbai
Bachelor of Pharmacy - BPharm
2013 — 2017
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