Manager / Senior Manager – Regulatory Affairs

Manager/Senior Manager Regulatory Affairs Job Description 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/State FDA 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 in alignment with current business needs · Provide Regulatory Support for timely new product launches Minimum Education: M. Pharm/B.

Pharm Minimum Experience Required: 8-15 years FSSAI experience desirable.