
Senior Regulatory Affairs Specialist
4 days ago
• 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 per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
• Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
• Ensure and lead regulatory compliance for biosimilar products
• Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products
• Escalate regulatory issues, progress, and metrics to the GRA Biosimilars functionKNOWLEDGE AND SKILLS
• Comprehensive understanding of Regulatory activities
• Experienced in analytical method development, method validation, method transfers and characterization of biologic products. Regulatory experience with product filings
• Ability to understand and communicate scientific CMC information
• Anticipate and prevent potential issues
• Ability to communicate regulatory strategies and requirements to ensure expectations are understood
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