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