Regulatory Affairs Officer

2 days ago


Andheri East Mumbai Maharashtra, India Brooks Laboratories Ltd Full time

**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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