Life Sciences BSc & MSc Job Openings at Biocon Biologics
Biocon Biologics is seeking a Senior Regulatory Manager with expertise in biologics and biosimilars registration across Emerging Markets. This role involves preparing regulatory dossiers, managing submissions, coordinating with affiliates and health authorities, and ensuring compliance for timely product approvals. If you have hands-on experience in regulatory filings and a passion for advancing biosimilars globally, this opportunity in Bengaluru is ideal for you.
About the Job
Biocon Biologics, a leader in biosimilars, is hiring a Senior Regulatory Manager in Bengaluru, Karnataka. This role focuses on regulatory submissions and approvals for biologics/biosimilars across Emerging Markets, including the Middle East, Asia, LATAM, Africa, and CIS regions. The ideal candidate will collaborate with affiliates, partners, and health authorities to ensure seamless registrations and effective lifecycle management.
Key Responsibilities
- Prepare, review, and submit regulatory dossiers (CTD/eCTD or regional formats) for biosimilars.
- Track and maintain knowledge of regional regulatory landscapes across GCC, CIS, ASEAN, LATAM, and Africa.
- Support product registrations, renewals, and variations to meet market requirements.
- Ensure submission planning aligns with product launch and lifecycle timelines.
- Respond to health authority queries in collaboration with CMC, clinical, and quality teams.
- Maintain dashboards, submission trackers, and country-specific regulatory repositories.
- Understand regional pathways for biosimilar approvals: reliance, abridged reviews, priority reviews.
- Apply knowledge of GCC-CTD, ASEAN CTD, and WHO biosimilar guidelines.
- Collaborate with local affiliates and partner companies to facilitate submissions.
- Use electronic submission platforms and ensure regulatory compliance throughout.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related discipline.
- Proven experience in filing and obtaining approvals for biologics/biosimilars in Emerging Markets.
- Strong knowledge of CTD structure, Module 1 customization, and regional submission formats.
- Prior exposure to biosimilar guidelines (WHO, GCC, SAHPRA, INVIMA, ANVISA).
- Proficiency with regulatory submission systems and platforms.
- Excellent project management, communication, and stakeholder coordination skills.
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