Manager Regulatory Affairs

Key Accountabilities

Propose efficient regulatory pathway for New Product Introduction Develop & implement regulatory strategies for new/generic product registrations incompliance 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, ProjectManagement, Medical, Clinical etc to deliver high quality dossiers, in accordance withbusiness priorities Responsible for end-to-end filing of New products(Drugs/Biologics/Biosimilars etc) toCDSCO (Central Drugs Standard Control Organization), State FDA etc. Well versed with filing application of ND/SND/FDC/Import Registration/Import licenceetc on SUGAM portal Address queries from CDSCO/SFDA on submitted applications, provide regulatorysupport for IPC/CDTL/CDL testing Manage submission of application dossiers with relevant regulatory authorities, monitorthe review process and take appropriate actions to obtain regulatory approvals as planned. Responsible for Subject expert committee (SEC) meetings including preparation of slidedeck in co-ordination with cross functional teams and SEC deliberationTrack all SEC meetings to identify and recommend new product ideas/opportunitiesaligned with current business needs Provide Regulatory Support for timely new product launches

Minimum Education

M. Pharm/B. Pharm

Minimum Experience Required

8-10 years