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Sr. Manager Pharma formulation Drug Regulatory Affairs - Pune

Sr. Manager Pharma formulation Drug Regulatory Affairs - Pune

HRD House

10 - 15 years

18 - 22 Lacs

Pune

Posted:1 month ago| Platform:

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Skills Required

Drug Regulatory Affairs Regulatory Affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

You will be responsible for, 1. Candidate will be based at corporate office of reputed pharma company at Pune & coordinate with all Regulatory Affairs functions related to plant, R&D and handle pan india operation. 2. Prepare registration dossier for procuring certificates/license from local FDA, DCGI this would entail thorough familiarity with FDA, online portal, Drug Act and its various Schedules. 3. Co-ordinate with QA and R&D departments for technical documents (manufacturing documents like batch records, specifications, analytical methods, validation reports, and Stability data) required to be incorporated in the registration dossiers. 4. Candidate will be responsible for to obtain additional product permissions, test license, Certificates. 5. Candidate will be responsible for to submit the required information to regulatory authorities. 6. Candidate will be responsible for obtain product permissions, test license, plan approval, etc Required Candidate profile 1. Candidate should be B. Pharma / M. Pharma / with minimum to 10 to 15 years experience in reputed Pharma Drug Regulatory Affairs plant, R&D for Pan India Operation 2. You should be good in preparation & review of product registration/renewal of dossiers (D & C Act) for Regulated markets. 3. You should be good in to check the artworks for compliance with regulatory and pharmacopoeia requirements of products. 4. You should be good in to ensure regulatory compliance as per D&C Act and Marketing authorizations

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Sr. Manager Pharma formulation Drug Regulatory Affairs - Pune