ExecutiveAM-Regulatory Affairs US market
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
About Client:
It is one of India’s largest pharmaceutical specializes in generic drugs active pharmaceutical ingredients (APIs) and biosimilars and is among the top generic drug suppliers in the U.S. and Europe.
Position - Regulatory Affairs (US market)
Key Responsibilities:
- Hands on experience with RA-US market
- Responsible for Life Cycle Management of Approved and Tentative Approved ANDAs/NDAs i.e. filing of supplements (CBE CBE-30 PAS Response to Queries Controlled Correspondence Annual Reports/Updates etc.
- Review and submission of Annual Reports/Updates (for ANDAs/NDAs PEPFAR applications).
- Good interpretation of FDA queries and drafting of responses. Good communication skills in getting responses from stakeholders and ensure to adhere for high quality and regulatory standards in preparation of responses.
- Evaluation and good interpretation of FDA guidance with respect to post approval changes (SUPAC IR MR Changes to an Approved NDA or ANDA and its Q&A CMC Post approval Manufacturing Changes To Be Documented in Annual Reports etc.) and submission post approval changes like CBE CBE-30 and Prior Approval Supplement (PAS) etc..
- Review of BMRs knowledge in specification clearance (for drug product drug substance and excipients etc) stability protocols
- Knowledge on eCTD USP monographs labelling and Preparation of Module 2 and 3 section as per the post approval changes.
- Knowledge on product correspondence controlled correspondence and general correspondence etc.
