Enzene Hiring for Regulatory Affairs Professionals

Enzene Walk-in Drive for Regulatory Affairs Professionals | Apply Now

Are you an experienced Regulatory Affairs (RA) professional looking for a career opportunity in the biotech and pharma industry? Enzene, a leading biotechnology company, hires Senior Executives, Assistant Managers, and Managers for its Regulatory Affairs team in Chakan, Pune. If you have domestic or global regulatory compliance expertise, this is a great opportunity to work on cutting-edge biologics and biosimilars.

Last Date to Apply: March 30, 2025
Job Location: Chakan, Pune
Open Positions: Sr. Executive, Assistant Manager, Manager
Qualification Required: M.Tech / MSc in Biology, Biotechnology, Biochemistry, Pharmacy, or related fields
Experience Required: 6 – 15 years

Job Roles & Responsibilities

1. Domestic Regulatory Affairs

• Strong understanding of regulatory frameworks for biologics, biosimilars, novel biologics, and vaccines in India and ROW (Rest of the World) markets.
• Provide regulatory input on procedural and documentation requirements defined by Health Authorities, including RCGM-PCS, CTA, MAA, PAC, and PSURs.
• Ensure compliance with Indian regulatory authorities and emerging markets.
• Handle regulatory product maintenance and submission processes.

2. Global Regulatory Affairs

• Draft and review eCTD sections for regulated markets, including Europe, USA, Canada, Brazil.
• Prepare briefing books for scientific advice from EMA, UK MHRA, and other authorities.
• Compile modules for BLA, NDA, and EU MAA filings.
• Perform eCTD sequence preparation and publishing.
• Develop regulatory strategies for biosimilar proteins, synthetic proteins, and new entities.
• Ensure compliance with M1 to M5 structure across different global regulatory authorities.

3. Developmental Quality Assurance (QA)

• Formulate quality and compliance strategies for R&D aligned with global regulatory expectations.
• Develop and implement quality standards, policies, and procedures for regulatory compliance.
• Review key product development documents such as clone development reports, process characterization reports, batch manufacturing records, bio-similarity reports, etc.

How to Apply?

Interested candidates can apply . Online here.  Ensure to submit your application before March 30, 2025!

Company & Job Summary Table