Asst Manager- Regulatory Affairs

<h2><b>Job Description:</b></h2><p><b>Qualifications:</b></p><ul><li><p>B. Pharm / M. Pharm / M.Sc</p></li></ul><p><b>Experience:</b></p><ul><li><p>10–14 years</p></li></ul><p><b>Key Responsibilities:</b></p><ul><li><p>Prepare, compile, and submit regulatory dossiers and submission data.</p></li><li><p>Manage Test and Manufacturing License applications with state and central drug authorities.</p></li><li><p>Handle regulatory submissions, variation filings, technical report writing, and query responses.</p></li><li><p>Ensure compliance with Drugs &amp; Cosmetics Act, New Drug &amp; Clinical Trial (CT) Rules, and GMP guidelines.</p></li><li><p>Ensure adherence to national and international regulatory requirements.</p></li><li><p>Review product labeling and artworks for regulatory compliance.</p></li><li><p>Liaise with state and central regulatory bodies (e.g., CDSCO, FDA) for submissions, follow-ups, and query resolutions.</p></li><li><p>Maintain up-to-date regulatory documentation for marketed products.</p></li><li><p>Respond to deficiency letters, queries, and compliance notices from health authorities.</p></li><li><p>Monitor and interpret evolving regulatory guidelines, policies, and trends.</p></li><li><p>Conduct regulatory impact assessments for change controls.</p></li><li><p>Manage post-approval activities, including variations, renewals, and line extensions.</p></li></ul><h2><b>Location:</b></h2>Ferring India Laboratories