Life Sciences Jobs | Biocon Biologics is Hiring | Apply Now
Looking for high-growth Life Sciences Jobs in the pharma industry? This latest opportunity under Biocon Careers offers an advanced Regulatory Affairs Job for professionals aiming to work in biosimilars and global regulatory strategy. If you want to level up your career in pharma, this role is a strong step forward.
- Job Title: Senior 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 delivering affordable biologics through advanced research and innovation. With a strong global presence across the US, EU, and other markets, it plays a key role in improving healthcare access. The organization is known for its cutting-edge R&D and robust pipeline. Through Biocon Careers, professionals gain exposure to global regulatory environments. It is a top destination for building impactful Life Sciences Jobs.
Key Responsibilities
- Develop and implement regional regulatory strategies for biosimilar registrations aligned with global strategy and business goals
- Conduct regulatory risk assessments and provide mitigation strategies during planning and execution
- Oversee preparation, review, and submission of CTD/eCTD dossiers for approvals, renewals, and variations
- Coordinate with CMC, clinical, non-clinical, and labeling teams to ensure complete and timely submissions
- Act as primary contact with health authorities and lead regulatory discussions to facilitate approvals
- Collaborate with regional partners and distributors for local submissions and regulatory coordination
- Manage lifecycle activities including variations, renewals, labeling updates, and compliance reporting
- Maintain regulatory databases and ensure timely implementation of post-approval changes
- Monitor regional regulatory guidelines and provide compliance updates and regulatory intelligence
- Work cross-functionally with QA, QC, SCM, Clinical, Commercial, and BD teams to support regulatory and business objectives
Qualification
Bachelor’s or Master’s degree in Life Sciences, or related field; Regulatory certification is a plus.
Skills Required
- Experience in regulatory affairs in the pharmaceutical/biotech industry, experience in biosimilars is 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.
- 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.
If you’re aiming to grow within Biocon Careers, this Regulatory Affairs Job offers unmatched exposure to global regulatory frameworks. Among high-level Life Sciences Jobs, this role stands out for its strategic impact and career advancement potential.
