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

Skills Required

regulatory approvals