Job Summary
We are seeking an experienced Assistant Manager - Regulatory Affairs to support US regulatory submissions and lifecycle management activities. The role requires strong hands-on experience with USFDA regulations, dossier preparation, and coordination with cross-functional teams.
Key Responsibilities
- Prepare, review, and submit ANDA, NDA, DMF, and supplements for the US market
- Support regulatory strategy and ensure compliance with USFDA guidelines
- Handle eCTD publishing, submissions, and lifecycle management
- Respond to USFDA queries, deficiency letters, and information requests
- Coordinate with R&D, QA, QC, Manufacturing, and external partners
- Track regulatory timelines and ensure on-time submissions
- Maintain regulatory documentation and submission archives
Required Skills & Qualifications
- 5-8 years of experience in US Regulatory Affairs
- Strong knowledge of USFDA regulations and guidelines
- Experience with ANDA/NDA/DMF submissions
- Familiarity with eCTD format and publishing tools
(ref:iimjobs.com)
