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Manager Regulatory Affairs Abbott

8.0 - 10.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Key Accountabilities Propose efficient regulatory pathway for New Product Introduction ? Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs ? Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc. related to new products filing ? Collaborate with other functions such as R&D, Quality, Supply chain, Project Management, Medical, Clinical etc to deliver high quality dossiers, in accordance with business priorities ? Responsible for end-to-end filing of New products(Drugs/Biologics/Biosimilars etc) to CDSCO (Central Drugs Standard Control Organization), State FDA etc. ? Wel...

Posted 1 month ago

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