Job Title: CMC Regulatory Affairs (Biologics) – Executive to Manager Company: Enzene Biosciences Ltd.

Location:
Bhosari, Pune (In office) Employment Type: Full-time

Experience:
3–15 years Function: Regulatory Affairs About Enzene Enzene Biosciences is a biopharmaceutical CDMO focused on biosimilars and biologics. Our EU-GMP certified facilities in Pune support Drug Substance and Drug Product development and manufacturing, and we also have a presence in New Jersey, USA. We partner with clients worldwide to bring affordable biologics to patients globally.

About the Role
We are expanding our CMC Regulatory Affairs team and are hiring at multiple levels across Global RA, Developmental RA and Domestic RA/CMC documentation. You’ll have the opportunity to work on regulatory submissions for biosimilars across the globe, in regulated markets (US, Europe, Brazil, Australia and more) and domestic markets. You’ll work closely with R&D;, Manufacturing, Quality and different clients across products.

Key Responsibilities
• Prepare IND/IMPD for clinical trial applications
• Draft and review eCTD dossier sections for biosimilars for regulated markets: US, EU, UK, Brazil, etc.
• Collate BLA/MAA applications and run CTD publishing
• Prepare briefing books for EMA/MHRA scientific advice, plus pre-submission meeting packages




• Prepare and submit briefing books for FDA BPD meetings (Type 1/2/3/4)
• Handle health (regulatory) authority and customer queries for different types of applications
• Provide regulatory input to stakeholders across development stages and the product lifecycle
• Review R&D; and technical documents against global regulatory

requirements:
MOAs, protocols, reports, specifications, bioassay and biosimilarity data
• Support domestic (DCGI/CDSCO) filings, tech transfer, and regulatory and customer audits
• Represent RA in cross-functional project teams and drive dossier planning and timelines Requirements
• M.
Pharm / M.
Sc in Biotechnology, Biochemistry, Life Sciences or a related field
• 3–15 years of experience in regulatory affairs; the level offered will depend on experience
• Hands-on experience with biologics/biosimilars is mandatory
• Understanding of US, EU and DCGI regulatory pathways for biosimilars
• Working knowledge of eCTD
• Strong technical review skills, attention to detail and accuracy
• Clear communication and the ability to work across functions Levels Open
• Executive / Senior Executive: dossier drafting and review, document review, domestic filings
• Assistant Manager / Manager: global submissions, HA interactions, briefing books, lifecycle strategy

📌 CMC Regulatory Affairs (India)
🏢 Enzene Biosciences
📍 India