Job Responsibilities:

- Preparation, review & submission of Post approval changes supplements.
- Responsible for review of OOS, OOT, Change control, deviation As per Regulatory guidelines.
- Monitoring of Post approval commitments for commercial batches.
- Preparation, review & submission of queries.
- Review of stability data of Exhibit batches & all the filling documents required for ANDA submission.
- Review of Finished product, In-process & API analytical documents for regulatory filing.
- Managing & responsible for review of Exhibit Process monitoring protocol & report for submission purpose.
- Maintain a regulatory database on site.
- Monitoring & compliance of Post approval commitments for commercial batches.

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Regulatory Affairs Professional (Dadra and Nagar Haveli and Daman and Diu)
🏢 Acme Services
📍 Dadra and Nagar Haveli and Daman and Diu