Are you passionate about advancing healthcare through biosimilars? Biocon Biologics, a global leader in biopharmaceuticals, is hiring a Regulatory Affairs Specialist in Bengaluru, Karnataka. This role offers an exciting opportunity to shape regulatory strategies for biosimilar products, ensuring compliance and driving global registrations. If you’re an expert in regulatory affairs with a knack for collaboration and strategic planning, this position is your chance to make a meaningful impact in the biopharmaceutical industry.
Responsibilities
As a Regulatory Affairs Specialist at Biocon Biologics, you will:
- Develop Regulatory Strategies: Create and execute CMC regulatory strategies for biosimilar products, focusing on global registrations and lifecycle management.
- Prepare Regulatory Documents: Draft high-quality documents, including CTAs, IND/IMPD, MAA/BLA, and DMF, ensuring compliance with ICH guidelines.
- Collaborate Cross-Functionally: Work with internal teams and external partners to align on regulatory deliverables and timelines.
- Ensure Compliance: Monitor and implement global regulatory requirements, maintaining filings throughout the product lifecycle.
- Provide Regulatory Guidance: Offer expertise on clinical and non-clinical strategies, reviewing CMC documents and protocols.
- Engage with Health Authorities: Participate in regulatory meetings and prepare briefing books for scientific advice.
- Monitor Regulatory Intelligence: Stay updated on global biosimilar regulations and assess their impact on competitive products.
Qualifications
To excel in this role, you should have:
- Education: Doctorate or Master’s degree in a relevant field (e.g., life sciences, pharmacy, or biotechnology).
- Experience: Proven regulatory affairs experience with product filings, ideally in biosimilars or biologics.
- Skills:
- Comprehensive knowledge of regulatory activities and ICH guidelines.
- Strong team collaboration and project management skills.
- Ability to communicate complex CMC information clearly.
- Expertise in DMF preparation and regulatory document drafting.
- Attributes: Proactive problem-solver with the ability to anticipate and mitigate risks.
Benefits
Joining Biocon Biologics offers:
- Competitive Salary: INR 8,00,000–12,00,000 per annum, based on experience.
- Career Growth: Opportunities to work on cutting-edge biosimilar projects with global impact.
- Collaborative Environment: Engage with top-tier professionals in a dynamic, innovative workplace.
- Health & Wellness: Comprehensive health benefits and wellness programs.
- Work-Life Balance: Flexible work arrangements in Bengaluru.
How to Apply
Ready to take the next step? Submit your resume and cover letter via the Biocon Biologics Careers Portal. Ensure your application highlights your regulatory affairs experience and expertise in biosimilars. Applications close on October 17, 2025. Don’t miss this opportunity to join a leader in biopharmaceutical innovation!
FAQs
Q: What is the role of a Regulatory Affairs Specialist at Biocon Biologics?
A: The specialist develops and executes regulatory strategies for biosimilar products, ensures compliance with global regulations, and collaborates with cross-functional teams to support product approvals.
Q: What qualifications are required for this position?
A: A Doctorate or Master’s degree in a relevant field, along with regulatory affairs experience, strong communication skills, and familiarity with ICH guidelines and DMF preparation.
