Join Now
Enzene, a leader in biologics and biosimilars, is excited to announce openings in our Regulatory Affairs (Domestic and Global) and Developmental QA teams. We’re seeking Senior Executives, Assistant Managers, and Managers with 6-15 years of experience to join us at our Chakan, Pune facility. If you have a background in Biology, Biotechnology, Biochemistry, Pharmacy, or a related field and are passionate about regulatory compliance and quality, apply by March 30, 2025!
Job Opportunities Overview
Departments: Regulatory Affairs and Developmental QA
We’re hiring for three specialized areas: Domestic Regulatory Affairs, Global Regulatory Affairs, and Developmental QA. These roles offer a chance to work on cutting-edge biological products and ensure global regulatory compliance.
Job Details
Regulatory Affairs (Domestic)
- Positions: Senior Executive / Assistant Manager / Manager
- Qualifications: M.Tech, M.Sc (Biology, Biotechnology, Biochemistry, Pharmacy, or related field)
- Experience: 6-15 years
- Responsibilities:
- Understand regulatory frameworks and trends for biologics, biosimilars, novel biologics, and vaccines in India and ROW markets
- Provide regulatory input for Indian and emerging market health authorities
- Review documents (e.g., RCGM-PCS, CTA, MAA, PAC, study protocols, PSURS)
- Manage regulatory product maintenance processes
Regulatory Affairs (Global)
- Positions: Senior Executive / Assistant Manager / Manager
- Qualifications: M.Tech, M.Sc (Biology, Biotechnology, Biochemistry, Pharmacy, or related field)
- Experience: 6-15 years
- Responsibilities:
- Draft and review eCTD sections for regulated markets (Europe, USA, Canada, Brazil, etc.)
- Prepare briefing books for scientific advice (EMA, UK HMRA, etc.)
- Collate modules for BLA/NDA/EU MAA submissions
- Handle sequence preparation and publishing using eCTD software
- Devise eCTD filing strategies and understand M1-M5 regulatory requirements
Developmental QA
- Positions: Senior Executive / Assistant Manager / Manager
- Qualifications: M.Tech, M.Sc (Biology, Biotechnology, Biochemistry, Pharmacy, or related field)
- Experience: 6-15 years
- Responsibilities:
- Formulate quality and compliance strategies for R&D per global standards
- Design and implement quality policies and procedures
- Review product development documents (e.g., clone development, process development, batch records, biosimilarity reports)
- Job Location for All Roles: Chakan, Pune
How to Apply
Application Process
Interested candidates with relevant experience should apply by March 30, 2025:
- Use the QR code provided in the original announcement (if available) to submit your application
- Alternatively, check Enzene’s official website or contact HR for submission details
Why Join Enzene?
Innovate with Impact
At Enzene, you’ll benefit from:
- Opportunities to work on biologics, biosimilars, and vaccines for global markets
- A collaborative environment focused on quality and regulatory excellence
- A chance to shape the future of pharmaceutical development in Pune
Quick Reference Table
| Department | Position | Qualification | Experience | Key Responsibilities |
|---|---|---|---|---|
| RA (Domestic) | Sr. Exec / Asst. Mgr / Mgr | M.Tech, M.Sc (Bio-related fields) | 6-15 Years | Regulatory framework, document review |
| RA (Global) | Sr. Exec / Asst. Mgr / Mgr | M.Tech, M.Sc (Bio-related fields) | 6-15 Years | eCTD drafting, global filings, strategy |
| Developmental QA | Sr. Exec / Asst. Mgr / Mgr | M.Tech, M.Sc (Bio-related fields) | 6-15 Years | Quality strategy, R&D document review |
We’re eager to welcome regulatory and QA experts to our team! Apply by March 30, 2025, and join Enzene in Chakan, Pune, to drive innovation in biologics and beyond!