Director of Regulatory Affairs

Job Type: Full Time

Job Description:

Primary Function: Ensure effective liaison with all the Regulatory & associated departments of Ministry of Health so as to achieve desired business objectives. And to ensure timely and seamless handling of any issue as and when required.  Liaison between Business Development & Product Development for expediting projects. Supporting procurement for early release of all kind of raw material releases from DRAP. Supporting BD for early release of Form-6 for Raw material for trial manufacturing. Coordination for all audits i.e. panel inspections for new molecules, GMP routine, FID inspections and international business audits. Experience: Director Level resource. Holding a senior position with preferably BD & Regulatory both under their domain. Having at least 15-20 years of experience in the field with excessive links to DRAP and other government bodies Export regulatory exposure is a plus. Pharmaceutical industry and government liaisons are preferred. Education: Minimum requirement Pharm. D with a Master’s degree in Business Administration, Health Sciences, LLB or any other equivalent area.

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