Regulatory Affairs Executive / Assistant Manager Asence Pharma

8.0 - 12.0 years

10 - 14 Lacs

Vadodara

Work from Office

About the Role: We are looking for an experienced and detail-oriented Regulatory Affairs Executive/Assistant Manager to join our team in the pharmaceutical industry. The ideal candidate will have in-depth knowledge of national and international regulatory requirements and a proven track record in handling regulatory submissions, dossier preparation, and compliance for pharmaceutical products. Key Responsibilities: Prepare, compile, and review regulatory submissions (CTD/eCTD formats) for product registrations, renewals, and variations as per regional and international guidelines. Ensure timely submission and follow-up of applications with regulatory authorities. Maintain up-to-date knowledge of changes in drug regulatory environments and communicate impacts to relevant departments. Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing, Supply Chain) to gather necessary documentation. Maintain regulatory documentation, databases, and records in compliance with internal procedures and regulatory standards. Assist in handling product labelling, artwork approvals, and packaging compliance. Respond to regulatory queries and deficiencies from health authorities in a timely manner. Candidate Profile: Bachelors or Masters degree in Pharmacy, Life Sciences, or related field. Minimum of 8 years of experience in Regulatory Affairs within the pharmaceutical sector. Strong understanding of regulatory frameworks. Experience with dossier preparation in CTD/eCTD formats. Familiarity with regulatory submission tools and document management systems. Excellent communication skills, both written and verbal. Strong analytical and problem-solving skills. Detail-oriented with the ability to manage multiple projects and deadlines.

Posted 1 day ago

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