Senior Regulatory Affairs Specialist
4 weeks ago
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 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 function
KNOWLEDGE 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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