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Ferring Pharmaceuticals, Inc. logo
Assistant Manager- Regulatory Affairs Ferring Pharmaceuticals, Inc.

10.0 - 14.0 years

0 Lacs

hyderabad, telangana

On-site

As a Regulatory Affairs Manager at Ferring India Laboratories, your role will involve the following responsibilities: - Prepare, compile, and submit regulatory dossiers and submission data. - Manage Test and Manufacturing License applications with state and central drug authorities. - Handle regulatory submissions, variation filings, technical report writing, and query responses. - Ensure compliance with Drugs & Cosmetics Act, New Drug & Clinical Trial (CT) Rules, and GMP guidelines. - Ensure adherence to national and international regulatory requirements. - Review product labeling and artworks for regulatory compliance. - Liaise with state and central regulatory bodies (e.g., CDSCO, FDA) fo...

Posted 3 days ago

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