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Regulatory Affairs Executive
Apotex Research
posted 3d ago
Job Role Insights
Flexible timing
Key skills for the job
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.
Employment Type: Full Time, Permanent
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What people at Apotex Research are saying
Rating based on 1 Executive Regulatory Affairs
review
Anonymous · Other
in Mumbai
Good work culture but many internal politics
- Skill development - Excellent
Not providing good percentage of promotion/increment
Executive Regulatory Affairs salary at Apotex Research
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