Biocon Biologics Is Hiring a Regulatory Affairs Manager (Biosimilars)
Biocon Biologics, a subsidiary of Biocon Ltd. and a global leader in biosimilars development, is recruiting for a Regulatory Affairs Manager to join its Global Regulatory Operations division.
If you have experience handling biological submissions, CMC reviews, and global market approvals (Emerging Markets, GCC, or US FDA/EMA), this position offers direct exposure to advanced biopharmaceutical regulatory filings.
Job Overview
- Company: Biocon Biologics Ltd.
- Position: Regulatory Affairs Manager — Biosimilars & Biologics
- Department: Global Regulatory Affairs (GRA)
- Location: Bengaluru, Karnataka, India (On-site / Campus)
- Role Type: Full-time
Core Responsibilities
As a Regulatory Affairs Manager at Biocon Biologics, you will manage regulatory filings for biosimilars across international markets:
- Dossier Preparation & Review: Prepare, compile, and review Module 1–5 CTD/eCTD submissions for biosimilar products, clinical trial applications (CTAs), and marketing authorization applications (MAAs).
- Health Authority Queries: Coordinate with internal CMC, R&D, clinical, and quality teams to formulate scientific responses to queries raised by international regulatory agencies (GCC, ANVISA, US FDA, EMA).
- Post-Approval Support: Manage product lifecycle maintenance, including post-approval changes, site transfers, renewals, and regulatory variations.
- Compliance Tracking: Maintain regulatory submission trackers, deficiency logs, and Regulatory Information Management Systems (RIMS).
Profile Requirements
| Requirement Category | Description |
|---|---|
| Education | Master’s degree (M.Pharm, M.Tech) or Doctorate (Ph.D.) in Biotechnology, Pharmacy, or Life Sciences. |
| Experience | 4–8 years in core regulatory affairs for biologics, monoclonal antibodies (mAbs), or biosimilars. |
| Technical Knowledge | In-depth understanding of WHO biosimilar guidelines, CTD structure, CMC documentation, and eCTD publishing standards. |
| Key Skills | Strong stakeholder coordination, technical documentation review, and agency communication skills. |
How to Apply
You can review active openings and submit your candidacy on Biocon's official talent acquisition network:
👉 Apply Directly on Biocon Careers Portal
(Search for "Regulatory Affairs Manager" or "Biosimilars" under the Bengaluru location filter to submit your application).