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Regulatory Affairs Specialist (RAD-US Market,CMC, M3) Creeno Solutions

6.0 - 11.0 years

10 - 18 Lacs

hyderabad

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Position: RAD-US Market, (CMC, M3) Qualification: M. Pharmacy (Pharmaceutics, Regulatory Affairs) Experience: 6-11 yrs Job Location: Hyderabad Job Type: Permanent Responsibilities: Hands on experience with RA-US market ; responsible for Approved and Tentative Approved ANDAs /NDAs [i.e., filing of supplements (CBE, CBE-30, PAS, Response to Queries, Controlled Correspondence, Annual Reports** /Updates etc.,) Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, an...

Posted 1 month ago

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