Abbott - Manager - Regulatory Affairs

Key Accountabilities:

- Propose efficient regulatory pathways for New Product Introduction (NPI).

- Develop and implement regulatory strategies for new and generic product registrations in compliance with relevant regulations and business requirements.

- Provide regulatory input on CMC data, BE & CT protocols, and study waiver justifications related to new product filings.

- Collaborate with cross-functional teams (R&D, Quality, Supply Chain, Project Management, Medical, Clinical, etc.) to deliver high-quality dossiers in alignment with business priorities.

- Manage end-to-end filing of new products (Drugs, Biologics, Biosimilars, etc.) with CDSCO (Central Drugs Standard Control Organization), State FDA, and other relevant authorities.

- Proficient in filing applications such as ND, SND, FDC, Import Registration, Import License, etc., via the SUGAM portal.

- Address queries from CDSCO/SFDA regarding submitted applications and provide regulatory support for IPC/CDTL/CDL testing.

- Oversee submission of application dossiers, monitor the regulatory review process, and take timely actions to secure approvals as planned.

- Lead Subject Expert Committee (SEC) meetings, including preparation of presentations in coordination with cross-functional teams and participation in SEC deliberations.

- Track SEC meetings to identify and recommend new product opportunities aligned with current business needs.

- Provide regulatory support to ensure timely new product launches.

Minimum Education - B. Pharm / M. Pharm/PG

Minimum Experience - 8-10 years of relevant regulatory affairs experience