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Regulatory Affairs Mgr work is to the Preparation and Submission of Drug Master Files, technical date packages, preparation of updates of different Active Pharmaceutical Ingredients (API's) for filing purpose to Regulatory Authorities of Various countries as per global regulatory requirements. Review, compilation and submission of documents in a scheduled time frame to regulatory agencies through regulatory agents. Proactive review of documents and data generation for anticipated queries and ensuring quick response to queries received from different regulatory bodies and customer to expedite the approval process. He would play an active role in supporting ISMS implementation program. Position is in our USFDA inspected facilities at Hyderabad.
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