Regulatory Affairs Officer

3 days ago


Andheri East, Maharashtra, India Brooks Laboratories Ltd Full time ₹ 6,00,000 - ₹ 9,00,000 per year
  • Preparation of CTD/ACTD dossiers for various ROW markets such as LATAM, CIS, MENA, Africa, and Asia, along with timely submissions.
  • Handling authority queries and submitting responses within defined timelines.
  • Reviewing artworks and obtaining final approvals from customers.
  • Coordinating with cross-functional teams including QA, QC, and R&D for required documents and technical responses.
  • Variation filing and product lifecycle management activities.
  • Maintaining tracking sheets for timely product and GMP renewals.
  • Monitoring registration timelines and ensuring timely data submission.
  • Following up with customers to obtain the current status of dossier submissions.
  • Arranging product samples and working standards for product registration and renewal purposes.
  • Coordinating with the Licensing team for obtaining COPP, FSC, and other administrative documents.

Job Type: Permanent

Pay: From ₹450,000.00 per year

Work Location: In person



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