Asst Manager- Regulatory Affairs
Ferring Pharmaceuticals
- Location
- Hyderabad, Telangana, India
- Job type
- Full-time
About the role
Ferring Pharmaceuticals
Website:
ferring.com
Job details:
Job Description:
Qualifications:
- B. Pharm / M. Pharm / M.Sc
Experience:
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
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