Alembic Pharmaceuticals Limited's rich legacy spanning over a century in the Indian Pharma Industry. With a steadfast commitment to quality and innovation, we continue to make significant strides in the pharmaceutical sector.
Post : Regulatory Affairs - Sr. Executive / Asst. Mgr./ Dy. Mgr
Job Criteria :
• B.Pharm or M.Pharm qualification having experience between 7-15 yrs. with dossier filling experience in MEXICO or ASEAN Country.
• Knowledge for review of quality documents like executed batch documents, method validation, change
• Good communication skill
Job Responsibility :
• Compilation and review of product license applications, variations, and renewals for Mexico or ASEAN countries as per regulatory requirements respectively with minimal supervision
• Manages electronic documents and creates electronic submissions in CTD format.
• Preparation and review of responses to authority questions during registration and product lifecycle.
• Keep track of assigned projects and follow-ups to ensure the Dossier is delivered as per set timeline/commitments.
• Designing, Reviewing & Approval of Artwork required for registration purposes.
• Dossier due diligence for products being in-licensed from other company
• Support in preparing the meeting materials as needed, eg, regulatory project status/submission/ approval information monthly, quarterly or yearly.
Job Location : Corporate Office - Vadodara
Interested professionals may share their CVs to hrd@alembic.co.in stating position code "RA-2025" in subject line.
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