Cadila Pharmaceuticals Limited is inviting applications for the position of Senior Manager – Regulatory Affairs (EU/UK/AUS/NZ) at its Dholka (near Ahmedabad, Gujarat) location. This is an excellent opportunity for experienced regulatory professionals looking to work on global submissions and lifecycle management in regulated markets.
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If you have strong expertise in EU, UK, Australia, and New Zealand regulatory submissions, dossier review, and lifecycle management, this role offers a dynamic platform to grow your career in the pharmaceutical industry.
🔑 Key Responsibilities
- Review registration & re-registration dossiers before submission across EU, UK, AUS & NZ markets
- Handle pre-approval and post-approval regulatory activities
- Prepare and manage query responses with global health authorities
- Maintain country-wise regulatory status of registered products
- Coordinate with R&D, QA, and QC teams for dossier filing and compliance
- Provide technical regulatory support for dossier preparation
- Prepare and review variation documents as per international guidelines
- Resolve regulatory issues related to commercial orders
- Support international tenders aligned with regulatory requirements
- Handle contract manufacturing queries, due diligence, and SAP-related tasks
🎓 Qualifications & Experience
- Bachelor’s or Master’s degree in Pharmacy / Life Sciences (B.Pharm / M.Pharm / M.Sc)
- Proven experience in Regulatory Affairs (EU/UK/AUS/NZ markets)
- Strong knowledge of:
- CTD/eCTD submissions
- ICH guidelines
- Regulatory lifecycle management
- Hands-on experience with global dossier preparation & submissions
- Excellent communication and coordination skills
💰 Salary (Estimated)
- ₹18 LPA – ₹28 LPA (based on experience and expertise in international regulatory markets)
🌟 Benefits
- Opportunity to work with a leading global pharmaceutical organization
- Exposure to regulated international markets (EU, UK, AUS, NZ)
- Collaborative work environment with cross-functional teams
- Career growth in Regulatory Affairs leadership roles
- Involvement in end-to-end regulatory lifecycle management
📍 Job Location
- Dholka, near Ahmedabad, Gujarat, India
📧 How to Apply
Interested candidates can share their updated CV at:
📩 savitri.thakor@cadilapharma.com
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