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 :

Ferring India Laboratories