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