Regulatory Affairs Jobs | Biocon Biologics is Hiring | Life Sciences Candidates Apply Now
Looking for Regulatory Affairs Jobs in the biotechnology industry? Biocon Biologics has announced an exciting opportunity for a Regulatory Affairs Specialist in Bengaluru. Through Biocon Careers, qualified professionals can contribute to global biosimilar registrations, regulatory strategy development, and product lifecycle management. This opportunity is ideal for candidates seeking Life Sciences Jobs that offer international exposure, regulatory expertise, and career growth in one of India’s leading biotechnology organizations.
- Job Title: Regulatory Affairs Specialist
- Location: Bengaluru, Karnataka, India (On-site)
About the Company
Biocon Biologics is a leading global biosimilars organization and a subsidiary of Biocon Limited. The company focuses on developing and commercializing affordable biologic therapies worldwide. With a strong portfolio across diabetes, oncology, immunology, and other therapeutic areas, Biocon Biologics serves patients in multiple international markets. The organization is recognized for its innovation-driven approach and commitment to improving healthcare accessibility through high-quality biosimilars.
Key Responsibilities
- Develop and implement regulatory strategies for biosimilar product registrations.
- Coordinate cross-functional regulatory activities and submissions.
- Prepare and review DMFs and regulatory dossiers.
- Support lifecycle management activities for biosimilar products.
- Prepare regulatory documents including CTAs, INDs, IMPDs, BLAs, and MAAs.
- Participate in regulatory meetings with global health authorities.
- Monitor global regulatory guidelines and compliance requirements.
- Support clinical and non-clinical regulatory strategies.
- Collaborate with global partners and internal stakeholders.
- Ensure regulatory compliance across product development and commercialization activities.
Education
Doctorate degree OR Master’s degree
Skills Required
- Comprehensive understanding of Regulatory activities.
- Regulatory experience with product filings.
- Team skills in working with partners.
- Familiarity with project management requirements.
- Ability to understand and communicate scientific CMC information.
- Anticipate and prevent potential issues.
- Ability to communicate regulatory strategies effectively.
Candidates searching for Regulatory Affairs Jobs in the biosimilars and biotechnology sector should not miss this opportunity at Biocon Biologics. Through Biocon Careers, selected professionals will gain valuable experience in global regulatory submissions, compliance strategies, and product development activities. If you are exploring Life Sciences Jobs that combine scientific knowledge with regulatory expertise, this position offers an excellent platform for long-term professional growth.
