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Brooks Laboratories Ltd
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Regulatory Affairs Officer

Regulatory Affairs Officer

Brooks Laboratories Ltd

0 years

|

4 - 0 Lacs

andheri east mumbai maharashtra

Posted:1 day ago| Platform: SimplyHired logo

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Skills Required

Work Mode

On-site

Job Description

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

More Jobs at Brooks Laboratories Ltd

Regulatory Affairs Officer

andheri east, mumbai, maharashtra

Experience: Not specified

Salary: Not disclosed

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Brooks Laboratories Ltd

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