The Regulatory Affairs Manager, will have to co-ordinate, structure and lead the dossier compilation & submission to the geographies assigned to them.
- Prepare, review, and compile regulatory dossiers as per country-specific guidelines (CTD/ACTD formats).
- Ensure completeness, accuracy, and compliance of all modules (administrative, quality, clinical as applicable).
- Manage end-to-end submission of dossiers to regulatory authorities across target markets.
- Maintain version control and documentation integrity for all submissions.
- Track status of all dossiers from submission to approval.
- Maintain a centralized tracker for submissions, queries, deficiencies, and approvals.
- Follow up with regulatory authorities and partners for timely progress.
- Manage variation filings, renewals, and post-approval changes.
- Review and respond to regulatory queries/deficiencies within defined timelines.
- Coordinate with manufacturers and internal teams to address gaps effectively.
- Ensure all submissions comply with local regulatory guidelines and updates.
- Stay updated with changing regulatory requirements across markets.
- Maintain an organized repository of all regulatory documents and correspondence.
- Develop and implement SOPs for dossier preparation and submission workflows.
- Ensure audit readiness and data traceability at all times.
- Support internal teams with regulatory insights for product registration planning.
Job Type: Full-time
Pay: ₹550,000.00 - ₹700,000.00 per year
Experience:
- ROW Market: 3 years (Required)
Work Location: In person
