Asst Manager- Regulatory Affairs

Job Description:

Qualifications:

• B. Pharm / M. Pharm / M.Sc

Experience:

• 10–14 years

Key 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) for submissions, follow-ups, and query resolutions.

• Maintain up-to-date regulatory documentation for marketed products.

• Respond to deficiency letters, queries, and compliance notices from health authorities.

• Monitor and interpret evolving regulatory guidelines, policies, and trends.

• Conduct regulatory impact assessments for change controls.

• Manage post-approval activities, including variations, renewals, and line extensions.

Location: