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Asst Manager- Regulatory Affairs

Asst Manager- Regulatory Affairs

ConfidentialHyderabad / Secunderabad, Telangana, India
21 days ago
Job description

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

    Skills Required

    Regulatory Submissions, Technical Report Writing

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    Asst Manager • Hyderabad / Secunderabad, Telangana, India