Looking to advance your career in Regulatory Affairs biosimilars? Biocon Biologics Limited is hiring a Regulatory Affairs Specialist in Bengaluru. This opportunity is ideal for professionals with 2–4 years of experience in regulatory submissions, CTD/eCTD dossier preparation, and biosimilar regulatory pathways, especially across MENA and CIS regions.
This role offers hands-on exposure to global regulatory strategy, health authority interactions, and lifecycle management—making it highly valuable for candidates aiming to build expertise in international regulatory affairs.
📌 Key Responsibilities
1. Regulatory Strategy & Planning
- Develop and execute regional regulatory strategies for biosimilars (MENA, CIS, Non-EEA)
- Align regional plans with global regulatory strategy
- Conduct regulatory risk assessments and mitigation planning
2. Dossier Preparation & Submission
- Prepare, review, and submit CTD/eCTD dossiers
- Manage submissions for MAA, renewals, and variations
- Collaborate with CMC, clinical, non-clinical, and labeling teams
3. Health Authority Engagement
- Act as primary liaison with regulatory authorities
- Handle technical discussions and query responses
- Coordinate with regional partners/distributors
4. Lifecycle Management
- Manage post-approval variations, renewals, and labeling updates
- Ensure compliance with regional regulatory timelines
- Maintain updated regulatory databases
5. Regulatory Compliance & Intelligence
- Track updates in biosimilar regulations and ICH guidelines
- Interpret regulatory changes and provide impact assessments
- Support audits and inspections
6. Cross-functional Collaboration
- Work with QA, QC, Clinical, SCM, Commercial & BD teams
- Support due diligence and licensing activities
🎓 Qualifications & Experience
- B.Pharm / M.Pharm / Life Sciences degree
- 2–4 years in Regulatory Affairs (biotech/pharma)
- Strong expertise in:
- Biosimilar regulatory pathways
- CTD/eCTD submissions
- MENA & CIS regulatory requirements
- Knowledge of:
- ICH guidelines
- SFDA & EMA reliance procedures
💡 Required Skills
- Regulatory strategy & submission expertise
- Strong project management skills
- Excellent communication (written & verbal)
- Attention to detail with strategic thinking
- Ability to manage multiple submissions simultaneously
💰 Salary & Benefits
- 💵 Salary: ₹3.5 – ₹5 LPA (industry-aligned for 2–4 yrs experience)
- 🌍 Exposure to global biosimilars markets
- 📈 Career growth in international regulatory affairs
- 🤝 Collaborative and innovation-driven work environment
📍 Job Location
- Bengaluru, Karnataka, India
🚀 Why This Role is Important
With increasing demand for biosimilars globally, professionals skilled in regulatory submissions (CTD/eCTD), MENA/CIS markets, and lifecycle management are highly sought-after. This role at Biocon Biologics provides direct exposure to global regulatory frameworks, making it a strong career accelerator in Regulatory Affairs.
📩 How to Apply
