Assistant Manager Regulatory Affairs
Current Compilation of dossiers in CTD, ACTD format & as per countries guideline & dispatch the same along with the required number of sample packs, raw materials, WS, etc for registration purpose. Reviewing of MFR, BMR, PDR, DMF, PV, FPS, FPT, RMS, RMT, CDP, Stability, & AMV, etc. of Ajanta as well as third party documents as per requirement of FA, AA, CIS & Iraq region. Gather all the various documentations and medical studies, PSUR, RMP required by each country when registering the products. Checking of artwork & various other related technical documents. Create a check list for all documents available & maintaining list, documents and records. Updating & maintaining the registration status, query status, registration certificate status, submitted dossier status, pending registrations status, planned dossier status. Study the nature of query received from agents and health authorities of respective countries and provides a suitable reply with supportive technical documents. Co-ordination with R&D, Quality Assurance., Quality Control & Production Departments as per Registration purpose. Coordination with manufacturer for FDA documents, QC/QA documents & for registration samples. Preparation of legal documents required for registration as per countries requirement. Eg. PP, COPP, FSC, etc. Preparation of registration Intimation, maintaining record of registered data. Provided training to newbies.