Cipla Is Hiring an Executive — Regulatory Affairs
Cipla, one of India's leading pharmaceutical multinationals, is recruiting for an Executive — Regulatory Affairs to join its Global Regulatory Operations division.
If you have experience preparing dossiers, coordinating with health authorities, and navigating global regulatory landscapes, this position offers direct exposure to international market submissions across ROW (Rest of the World) and Emerging Markets.
Job Overview
- Company: Cipla Ltd.
- Position: Executive / Senior Executive — Regulatory Affairs
- Department: Global Regulatory Affairs (GRA)
- Location: Mumbai / Vikhroli, Maharashtra, India (Hybrid)
- Role Type: Full-time
Core Responsibilities
As a Regulatory Affairs Executive at Cipla, you will drive regulatory compliance and dossier submissions to expand product portfolios in global markets:
- Dossier Compilation: Prepare, compile, and review CTD / eCTD regulatory dossiers (Modules 1 through 5) for market authorization applications (MAA).
- Regulatory Lifecycle Management: Manage post-approval changes, variations, renewals, and response strategies for Health Authority queries.
- Cross-Functional Coordination: Collaborate with R&D, Quality Control, Plant Operations, and Clinical Teams to gather technical data (COA, stability studies, manufacturing processes).
- Compliance Tracking: Stay updated on regional regulatory guidelines (CDSCO, US FDA, WHO, MHRA) and update internal regulatory strategy trackers.
Profile Requirements
| Requirement Category | Description |
|---|---|
| Education | Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm). |
| Experience | 2–5 years of hands-on experience in Regulatory Affairs (Formulations / APIs). |
| Technical Knowledge | Solid experience with CTD/eCTD dossier creation, ROW/Emerging Market guidelines, and lifecycle maintenance. |
| Key Skills | Strong technical writing, cross-department coordination, and attention to detail. |
How to Apply
You can review active openings and submit your application directly on Cipla’s official careers network:
๐ Apply Directly on Cipla Careers Portal
(Search for "Regulatory Affairs" under the Mumbai location filter or look for Job Code RA-EXEC-MUM to apply).