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Amneal Pharmaceuticals logo
Senior Executive - Regulatory Affairs | Post Approval Amneal Pharmaceuticals

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

Role Overview: You should have a good knowledge of ANDA submission activities and post-approval procedures along with related ICH and USFDA guidelines. Your responsibilities will include API DMF review in accordance with USFDA regulatory requirements, exposure to various dosage forms, preliminary review of change cases, drafting annual reports, reviewing submission packages, drafting controlled correspondence, and ensuring regulatory submissions are completed without delay. Coordination with cross-functional teams and maintaining regulatory information will also be part of your role. Key Responsibilities: - Review API DMF with respect to USFDA regulatory requirements - Understand and brief m...

Posted 2 months ago

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