Biocon Biologics is offering an exciting opportunity for professionals in regulatory affairs to join their growing team in Bengaluru. This role is ideal for candidates with experience in biosimilars and international regulatory submissions, especially across MENA and CIS regions. If you are looking to work with a globally recognized biosimilars organization and contribute to improving healthcare access, this could be the right opportunity for you.
Job Overview
Company: Biocon Biologics
Position: Regulatory Affairs Specialist
Location: Bengaluru, Karnataka, India
Job Type: Full-Time
Roles and Responsibilities
Regulatory Strategy & Planning
- Develop and execute regional regulatory strategies for biosimilar product registrations
- Ensure alignment with global regulatory goals and business priorities
- Conduct risk assessments and implement mitigation strategies
Dossier Preparation & Submission
- Prepare, review, and submit CTD/eCTD dossiers for approvals, renewals, and variations
- Coordinate with cross-functional teams for documentation
- Ensure timely submissions as per regulatory timelines
Agency Engagement & Coordination
- Act as a point of contact with health authorities
- Lead discussions with regulatory agencies for approvals
- Collaborate with regional partners for submissions and insights
Lifecycle Management
- Handle post-approval changes, renewals, and labeling updates
- Maintain updated regulatory databases and documentation
Compliance & Intelligence
- Monitor regional regulatory updates and guidelines
- Ensure compliance with evolving regulatory requirements
- Support inspections and audits when required
Cross-functional Collaboration
- Work closely with QA, QC, SCM, Clinical, and Business teams
- Support business development and partnership evaluations
Required Qualifications
- Bachelorโs or Masterโs degree in Pharmacy, Life Sciences, or related field
- Regulatory certification is an added advantage
- Experience in pharmaceutical or biotech regulatory affairs
- Strong knowledge of biosimilar regulatory pathways and ICH guidelines
- Mandatory experience in MENA and CIS regulatory submissions
- Familiarity with SFDA and EMA reliance procedures
Skills & Competencies
- Strong project management and organizational skills
- Excellent communication and documentation abilities
- Strategic thinking with high attention to detail
- Ability to manage multiple tasks efficiently
- Collaborative and proactive mindset
Salary and Benefits
- Estimated Salary: โน6,00,000 โ โน12,00,000 per annum
- Health insurance and employee wellness programs
- Career growth opportunities in a global biotech company
- Exposure to international regulatory markets
- Learning and development support
About Biocon Biologics
Biocon Biologics Limited is a subsidiary of Biocon Limited and a global leader in biosimilars. The company focuses on delivering affordable biologic therapies across diabetes, oncology, immunology, and other critical therapeutic areas. With a strong pipeline and presence in global markets such as the US, EU, and Japan, Biocon Biologics continues to transform healthcare access worldwide.
How to Apply
Interested candidates can apply through the official Biocon Biologics careers portal or LinkedIn job listing. Ensure your resume highlights your experience in regulatory submissions and biosimilars.