Job Description
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
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
- 5-8 years of...
Apply for this Position
Ready to join Confidential? Click the button below to submit your application.
Submit Application