recruiter at Relevant4u
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Manager - Drug Regulatory Affairs - Hospital - M.Pharma/B.Pharma (9-15 yrs)
Job Description :
- Good knowledge of Drug Master File USDMF, CEP and ASMF. Thorough knowledge of ICH guidelines.
- Experience to review DMF amendments filed by DMF holder and check impact on ANDA filings.
- Expertise in Life Cycle Management of DMF changes, enrolling, monitoring and assessment.
- Should develop and establish robust system for change management process.
- Expertise to handle DMF change notification, write change assessment, determine change category and change implementation strategy for US market.
- Strategize DMF changes, should be optimistic to support Business, Supply reliability and Continuity of operation.
- Provide on time support to handle DMF related deficiencies, prepare action plan and should able to bring consensus with DMF holder.
- Should have good analytical knowledge, able to review Analytical method validation and perform Pharmacopoeial evaluation.
- Sound knowledge in Early stage development for finalization of ROS, selection of Regulatory starting material (ICH-Q11), Carry over studies and Control strategies required for Drug substance. Should have knowledge of Fate & Purge study and QbD aspects.
Qualification : Msc / Mpharma / Bpharma