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

(ref : iimjobs.com)