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IMPRONICS DIGITECH PRIVATE LIMITED logo
Assistant Manager - Regulatory Affairs IMPRONICS DIGITECH PRIVATE LIMITED

4.0 - 8.0 years

0 Lacs

maharashtra

On-site

Role Overview: As an experienced Regulatory Affairs Specialist with a strong educational background in M. Pharmacy, you will be responsible for various key activities related to regulatory affairs in the pharmaceutical industry. Your expertise in regulatory activities such as CTD dossier preparation, query solving, and thorough knowledge of ICH guidelines will be crucial for the successful submission of dossiers to regulatory authorities. Key Responsibilities: - Prepare and submit new dossiers in compliance with regulatory requirements - Conduct gap analysis of dossiers to ensure completeness - Compile dossiers in eCTD format for submission to regulatory authorities - Coordinate the submissi...

Posted 1 month ago

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