Regulatory Affairs Manager

Experience- 10-12 Years

Location- Mumbai

Mandatory Skills- Regulatory Affairs, CDSCO,DCGI, SUGAM Portal

Only those candidates can apply whose salary is not more than 24 LPA

Looking from Only Pharma Companies

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

Interested candidates please share their resume on sudha.kumari@rightadvisors.com.