Regulatory Affairs Officer
2 days ago
- 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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Sr. Manager – Regulatory Affairs
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