Manager / Senior Manager \u2013 Regulatory Affairs

Job Description

Manager/Senior Manager Regulatory Affairs
Job Description

Key Accountabilities:

Propose efficient regulatory pathway for New Product Introduction
u00B7 Develop & implement regulatory strategies for new/generic product registrations in
compliance with relevant regulations and the business needs
u00B7 Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc.
related to new products filing
u00B7 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
u00B7 Responsible for end-to-end filing of New products(Drugs/Biologics/Biosimilars etc) to
CDSCO (Central Drugs Standard Control Organization), State FDA etc.
u00B7 Well versed with filing application of ND/SND/FDC/Import Registration/Import licence
etc on SUGAM portal
u00B7 Address queries from CDSCO/State FDA on submitted applications, provide regulatory
support for IPC/CDTL/CDL testing
u00B7 Manage submission of application dossiers with relevant regulatory authorities, monitor
the review process and take appropriate actions to obtain regulatory approvals as planned.
u00B7 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
u00B7 Provide Regulatory Support for timely new product launches

Minimum Education: M. Pharm/B. Pharm
Minimum Experience Required: 8-15 years

FSSAI experience desirable.