Assistant Manager - Regulatory Affairs - US Market

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