Manager CMC Regulatory Affairs

Manager overseeing CMC regulatory strategy and compliance for biologic products across development, submissions, and post-market programs. The role involves leading regulatory initiatives, collaborating across global teams, and ensuring adherence to applicable regulations in an on-site position.

Responsibilities

• Lead CMC regulatory strategies for assigned biologic products across all development phases
• Support CMC activities from early phase through submission and post-market monitoring
• Evaluate product changes and deviations for regulatory impact and filing requirements
• Review regulatory filings for compliance with applicable regulations and industry guidelines
• Facilitate regulatory authority interactions, including meetings and information request responses

Requirements

• Bachelor's degree with 6+ years or advanced degree with 3+ years in pharmaceutical, biotechnology, or Health Authority settings
• 2–4 years of CMC Regulatory Affairs experience with worldwide regulations
• Strong understanding of global CMC regulatory requirements and guidelines
• Experience delivering CMC sections of marketing authorizations, CTAs, INDs, and post-approval submissions
• Experience with biologic products preferred
• FDA or other regulatory authority engagement experience preferred
• Strong communication, negotiation, strategic thinking, and problem-solving capabilities