Job Description
1. Coordinate regulatory projects between internal departments, manufacturing facilities, regulatory teams, and external regulatory pharmacists, consultants, and agents.
2. Work closely with Quality Assurance (QA), Quality Control (QC), Production, R&D, Packaging Development, and other manufacturing-related departments to obtain required technical information and documentation.
3. Review regulatory observations, technical queries, and documentation requests received from regulatory authorities, consultants, distributors, and international partners.
4. Convert regulatory and technical requirements into clear action points, assign responsibilities, establish timelines, and follow up with the relevant departments until completion.
5. Review technical documents, including product specifications, certificates of analysis, stability data, analytical methods, validation documents, manufacturing information, artworks, and GMP-related records.
6. Coordinate the preparation and availability of dossiers, product samples, reference standards, impurity standards, working standards, legalized documents, certificates, and other submission requirements.
7. Identify missing information, documentation discrepancies, technical inconsistencies, and potential delays and coordinate with the responsible departments to resolve them.
8. Prepare professional emails, meeting minutes, technical clarifications, project updates, action lists, and status reports for internal and international stakeholders.
9. Maintain detailed trackers for product registrations, regulatory observations, documentation status, samples, standards, departmental responsibilities, and submission timelines.
10. Support regulatory submissions, renewals, variations, deficiency responses, and product-launch activities by ensuring that all technical, analytical, and manufacturing inputs are complete and provided within the required timelines.
Pay: ₹30,000.00 - ₹50,000.00 per month
Work Location: In person
