Strategy Lead, CMC Mature, Regulatory Affairs

Job Responsibilities

• Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with FDA expectations and global standards.
• Prepare and review technical regulatory documents to submit to regulatory authorities, including the FDA, to support lifecycle management of established vaccines.
• Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance to ensure compliance with U.S. regulatory requirements, including Good Manufacturing Practices (GMPs).
• Serve as Point of Contact for the FDA to receive and respond to general inquiries, notifications, and requests for information.
• Lead discussions in formal meetings and other engagements with the Agency.
• Identify risks and propose mitigation strategies to ensure smooth regulatory processes.
• Mentor and train team members, fostering a culture of continuous improvement.

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field (advanced degree preferred)
• 2+ years of experience in CMC regulatory affairs, with a focus on IND and BLA submissions to the FDA
• Experience as a liaison for FDA communications
• CMC experience for biologics, including regulatory requirements and technical content for submissions
• Comprehensive understanding FDA regulations, including 21 CFR, ICH guidelines, and GMP/GDP requirements related to biologics
• Experience in global CMC regulatory requirements and drug development processes
• Experience with reviewing and preparing CMC submission components, particularly eCTD Module 3
• Experience with manufacturing processes for biologics, including formulation, quality control, and analytical methods
• Experience translating technical and scientific information into clear, concise regulatory submissions
• Experience with mature product lifecycle management and post-approval changes