Regulatory Affairs Specialist Biocon Biologics

4.0 - 6.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in emerging markets. Key Activities required for this job are as below Develop and implement regulatory strategies for biosimilar products in LATAM. Prepare, review, and submit dossiers for marketing authorization applications (MAAs), renewals, and variations in compliance with local requirements. Ensure adherence to regional regulatory reu...

Posted 2 days ago

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