Torrents Pharmaceuticals invites for Regulatory Affair Executive - 3 posts
Torrent Pharmaceuticals Limited, is a dominant player in the therapeutic areas of cardiovascular (CV) and central nervous system (CNS) and has achieved significant presence in gastro-intestinal, diabetology, anti-infective and pain management segments. Torrent Pharma’s competitive advantage as a manufacturer stems from its world-class manufacturing facilities. Its manufacturing facilities at Indrad, Gujarat, comply with WHO, cGMP, MHRA and TGA norms and have received ISO 9001, ISO 14001 and OHSAS 18001
Post: Regulatory Affair Executive
* Preparing checklist on the basis of guidelines.
* Checking documents during product development stage as per the check list.
* Reviewing technology transfer documents like STPs, method validation protocol and report, packaging material specification, finished product specification, stability protocol and MPDs.
* Reviewing manufacturing documents like MFC, MPD, BMR, BPR, process validation protocol/report, stability protocol/report, sampling protocol, process validation protocol and product development report, COA, Axipient specification, GMP certificates, QC report, Patent related documents and QOS.
* Reviewing of clinical documents like BE protocol and report.
* Compiling dossier.
* Evaluating queries raised by Regulatory Authority and preparing draft response for the same.
* Preparing Technology Transfer documents for commercial batches and export order authorization.
* Reviewing and releasing purchase order and clearing the documents related to commercialization.
Good subject knowledge of Regulatory Affairs & latest updations in the guidelines
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