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Biocon Biologics logo
Regulatory Affairs Manager Biocon Biologics

12.0 - 15.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Key Responsibilities: 1. Regulatory Strategy & Planning Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. Ensure alignment with global regulatory strategy and business priorities. Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. Ensure submission timelines are m...

Posted 1 month ago

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