Regulatory Affairs Jobs | Biocon Biologics Hiring in Bengaluru
A rare chance has emerged for professionals seeking regulatory affairs jobs at Biocon Biologics in Bengaluru. This opportunity is ideal for candidates with a background in biotechnology and a passion for making a difference in the healthcare sector. Biocon career paths offer a dynamic environment for those eager to drive innovation in biotechnology jobs, making a significant impact on global health.
- Position: Regulatory Affairs Manager
- Location: Bengaluru, Karnataka, India (On-site)
- Job Type: Full-time
About the Company
Biocon Biologics is a fully integrated global biosimilars organization based in India. It leverages cutting-edge science and innovative technology to lower treatment costs while improving healthcare outcomes. With a strong research pipeline, Biocon Biologics is committed to transforming healthcare through affordable access to medicines for millions of patients worldwide. The organization has a diverse portfolio that includes biosimilars for diabetes, oncology, and other non-communicable diseases.
Key Responsibilities
- Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for Biosimilars in Emerging Markets.
- Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, LATAM, and Africa.
- Support product registrations, renewals & variations.
- Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management.
- Respond to health authority queries in coordination with CMC, clinical, and quality teams.
- Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines.
- Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc.
- Familiarity with GCC-CTD and regional WHO biosimilar guidelines.
Eligibility Criteria
- Bachelor’s or Master’s degree in Life Sciences, Biotechnology, or related field.
Skills Required
- Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets.
- Knowledge of CTD structure, Module 1 customization, and regional submission formats.
- Strong project management, communication, and stakeholder coordination skills.
Regulatory affairs jobs at Biocon Biologics offer an outstanding opportunity for qualified candidates to make a significant impact in the biotechnology field. With a commitment to innovation and excellence, Biocon Biologics is looking for professionals eager to contribute to the advancement of healthcare. This Biocon career path is ideal for those passionate about biotechnology jobs and improving patient outcomes. Interested candidates are encouraged to apply to join a leading organization in the biotechnology sector.
