Manager - Regulatory Affairs - Pharma

Experience: 10-12 Years.

Location: Mumbai.

Mandatory Skills: Regulatory Affairs, CDSCO,DCGI, SUGAM Portal.

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: Pharm/B.