Regulatory Affairs Jobs | Biocon is Hiring | Apply Before You Miss!!
Are you looking for exciting Life Sciences Jobs at Biocon? Here’s a great opportunity from Biocon Biologics for the position of Regulatory Affairs Specialist in Bengaluru. This role is ideal for candidates seeking Regulatory Affairs Jobs in a globally recognized biosimilars organization. Candidates from Biotechnology, Life Sciences, and related disciplines can gain valuable experience in international regulatory submissions, compliance management, and global product registrations while building a rewarding career in regulatory affairs.
- Job Title: Regulatory Affairs Specialist
- Location: Bengaluru, Karnataka, India (On-site)
- Job Type: Full-time
About the Company
Biocon Biologics is a global biosimilars organization focused on improving access to affordable healthcare worldwide. The company develops and commercializes biosimilars across multiple therapeutic areas, including diabetes, oncology, and immunology. With a presence in over 100 countries and a strong portfolio of biosimilar products, Biocon Biologics continues to expand its global footprint and innovation capabilities.
Key Responsibilities
- Develop regulatory strategies for biosimilar registrations.
- Manage CTD/eCTD dossier preparation and submissions.
- Coordinate with CMC, Clinical, Non-Clinical, and Labeling teams.
- Engage with health authorities and regulatory agencies.
- Handle renewals, variations, and lifecycle management activities.
- Monitor regulatory guidelines and compliance requirements.
- Support inspections and regulatory intelligence activities.
- Collaborate with QA, QC, SCM, Clinical, Commercial, and Business Development teams.
Qualifications & Experience
- Bachelor’s or Master’s degree in Life Sciences, or related field; Regulatory certification is a plus.
- Experience in regulatory affairs in the pharmaceutical/biotech industry, with experience in biosimilars preferred.
- Strong understanding of regulatory pathways for biosimilars (clinical and analytical similarity requirements) and ICH guidelines.
- Experience with regulatory submissions in MENA and CIS countries is mandatory.
- Familiarity with SFDA, EMA reliance procedures, and dossier localization requirements.
Skills Required
- Strong project management and organizational skills.
- Excellent written and verbal communication skills.
- Strategic thinking with attention to detail.
- Proactive, collaborative, and culturally aware.
- Ability to manage multiple priorities in a fast-paced environment.
Opportunities in global regulatory affairs continue to grow as biosimilars expand worldwide. This position at Biocon Biologics provides valuable exposure to international regulatory pathways, health authority interactions, and biosimilar product approvals. Candidates seeking impactful Life Sciences Jobs and long-term growth in the biotechnology sector should consider applying.
