- Develop and execute regulatory submission plans for assigned products and markets.
- Manage end-to-end lifecycle of regulatory submissions including filings, responses, and approvals.
- Coordinate with regulatory authorities and local agents for submission follow-ups and clarifications.
- Track, update, and maintain records of submissions, responses, and regulatory approvals.
- Liaise with Quality Assurance, R&D, and Production teams for timely and accurate documentation.
- Support preparation, compilation, and review of dossiers, variations, and renewal submissions.
- Assist in drafting and coordinating responses to regulatory queries and deficiencies.
- Monitor submission timelines and escalate delays or gaps to the Assistant Manager.
- Ensure regulatory documentation complies with prescribed formats and authority requirements.
- Execute approved regulatory plans without deviation from defined strategy and timelines.
Job Types: Full-time, Permanent, Fresher
Pay: ₹30,000.00 - ₹50,000.00 per month
Benefits:
- Flexible schedule
- Provident Fund
- Work from home
Work Location: Hybrid remote in Dehradun, Uttarakhand
