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.