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Inviting candidates for Specialist - Regulatory Affairs
Responsibilities:-
• Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products of small molecules/ pharma, large molecules/ biologicals, etc.
• Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management submissions under direction of team scientists.
• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Able to prioritize & execute the project acco