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Apotex
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Regulatory Affairs Executive

Job Expired: This job listing has expired.

Regulatory Affairs Executive

3 - 6 years

|

7 - 8 Lacs

Posted:9 months ago| Platform:

Apply

Skills Required

Product lifecycle management OSD Regulatory Affairs Life Cycle Management PLCM Regulatory Submissions

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities

Prepare dossiers, variations, renewals, and amendments for regulatory submissions.
Coordinate with CTD/eCTD vendors for preparation of dossiers.
Review artwork, labeling, and specifications for regulatory compliance.
Maintain master files and variation records according to ICH guidelines.
Ensure timely submission of applications to relevant authorities.

Desired Candidate Profile

3-6 years of experience in Regulatory Affairs (dossier preparation & submission).
Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution.
Strong understanding of Life Cycle Management (LCM), Product Lifecycle Management (PLCM), OSD regulations.

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