Senior Regulatory Manager Biocon Biologics

0.0 years

0 Lacs

bengaluru, karnataka, india

On-site

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, and Africa. Support product registrations, renewals & variations. Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management. Respond to health authority queries in coordination with CMC, clinical, and quality teams. Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines. Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc. Familiarity with GCC-CTD, ASEAN CTD, and regional WHO biosimilar guidelines. Experience working with local affiliates or partner companies in Emerging Markets. Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc. Experience with regional electronic submission platforms. Qualifications: Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, or related field. Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets. Knowledge of CTD structure, Module 1 customization, and regional submission formats. Strong project management, communication, and stakeholder coordination skills Show more Show less

Posted 1 day ago

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