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Biocon Biologics Limited logo
Regulatory Affairs Manager Biocon Biologics Limited

9.0 - 13.0 years

9 - 19 Lacs

bengaluru

Work from Office

JOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements • Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained pe...

Posted 4 days ago

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