V-Ensure Pharma Technologies Hiring Drug Regulatory Affairs – EU Market
- Career Opportunity for B Pharm/M.Pharm in Drug Regulatory Affairs – V-Ensure Pharma, Navi Mumbai
- About V-Ensure Pharma Technologies Pvt. Ltd.
- Key Responsibilities – Drug Regulatory Affairs (EU Market)
- Strategic Regulatory Oversight
- Coordination & Documentation
- Submission & Compliance
- Desired Candidate Profile
- Educational Qualification
- Experience
- Location
- Why Join V-Ensure Pharma?
- Summary Table
B Pharm / M.Pharm Job Opening – Manager/Sr. Manager Drug Regulatory Affairs – 15+ Years Experience – Navi Mumbai
Exciting opportunity for B Pharm/M.Pharm professionals with 15+ years’ experience in Drug Regulatory Affairs (EU Market) at V-Ensure Pharma, Navi Mumbai.
Career Opportunity for B Pharm/M.Pharm in Drug Regulatory Affairs – V-Ensure Pharma, Navi Mumbai
If you are an experienced pharmaceutical professional with a strong background in drug regulatory affairs, especially in the EU market, here’s a golden opportunity to advance your career. V-Ensure Pharma Technologies Pvt. Ltd., located in Koparkhairane, Navi Mumbai, is currently hiring for a Manager / Sr. Manager – Drug Regulatory Affairs role. Ideal candidates will hold a B Pharm or M.Pharm degree and bring 15 to 20 years of relevant experience managing EU regulatory submissions.
This article outlines everything you need to know about the position, the company, job responsibilities, and how to apply.
About V-Ensure Pharma Technologies Pvt. Ltd.
V-Ensure Pharma is a fast-growing pharmaceutical technology company that specializes in regulatory consulting and formulation development for global markets. With a strong presence in regulatory filings across multiple regions, the company offers professionals a collaborative, performance-driven environment with high-impact global projects.
Key Responsibilities – Drug Regulatory Affairs (EU Market)
Strategic Regulatory Oversight
- Lead and manage the EU and UK regulatory team.
- Define country-specific regulatory strategy to ensure timely submissions and approvals.
- Lead the preparation and review of regulatory documentation in line with current international standards.
Coordination & Documentation
- Coordinate cross-functional departments including ADL, FRD, QA, and Analytical Labs to gather required documents.
- Work closely with BD, clients, and vendors for regulatory support and compliance.
- Review Chemistry, Manufacturing and Controls (CMC) documentation for accuracy before dossier compilation.
Submission & Compliance
- Prepare, review, and submit Dossiers in CTD and regional formats.
- Address queries from clients and Ministry of Health (MOH) for successful market approvals.
- Handle post-approval regulatory documentation and monitor status.
- Manage site transfer documents and ensure compliance across manufacturing locations.
Desired Candidate Profile
Educational Qualification
- Bachelor of Pharmacy (B Pharm)
- Master of Pharmacy (M.Pharm)
Experience
- 15 to 20 years of hands-on experience in Drug Regulatory Affairs
- Deep knowledge and prior exposure to EU and UK regulatory procedures is mandatory
Location
Workplace: Koparkhairane, Navi Mumbai, Maharashtra
V-Ensure’s Navi Mumbai facility is well-connected and offers a corporate working environment ideal for senior professionals.
Why Join V-Ensure Pharma?
- Exposure to high-level regulatory strategy across EU regions
- Work in a dynamic, innovation-driven environment
- Opportunity to lead and shape a regulatory team for international markets
- Competitive compensation and growth trajectory in a global regulatory role
Summary Table
| Company Name | V-Ensure Pharma Technologies Pvt. Ltd. |
|---|---|
| Vacancies in Department | Drug Regulatory Affairs – EU Market |
| Required Education | B Pharm / M.Pharm |
| Experience Required | 15–20 Years in EU DRA |
| Job Location | Koparkhairane, Navi Mumbai |
To apply for this job email your details to talent@v-ensure.com
