Manager Regulatory Affairs

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.  Well versed with filing application of ND/SND/FDC/Import Registration/Import licence etc on SUGAM portal  Address queries from CDSCO/SFDA on submitted applications, provide regulatory support for IPC/CDTL/CDL testing  Manage submission of application dossiers with relevant regulatory authorities, monitor the review process and take appropriate actions to obtain regulatory approvals as planned.  Responsible for Subject expert committee (SEC) meetings including preparation of slide deck in co-ordination with cross functional teams and SEC deliberation Track all SEC meetings to identify and recommend new product ideas/opportunities aligned with current business needs  Provide Regulatory Support for timely new product launches Minimum Education M. Pharm/B. Pharm Minimum Experience Required 8-10 years Show more Show less