Flagship Biotech International Pvt. Ltd. Hiring for RA Executives

Department: Regulatory Affairs
Job Location: Mahape (Navi Mumbai)
Experience: 1 – 4 years
Job details:
1. Preparation of dossier as per country guidelines (CTD, ACTD, ECTD and Country specific).
2. Submission of dossier in timely manner.
3. Handling product renewals, variation and site change.
4. Coordination with manufacturing site and other department for the documents required for compilation of dossier.
5. Review of documents received from manufacturing site (BMR, Specification, Method of Analysis, PV, PDR and Stability).
6. Review of artwork (PIs, PILS, Labeling documents).
7. Query solving and Gap analysis.

Those interested can share your resume at hr@flagshipbiotech.com or call us at 02-40659260