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 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

Strategy Lead, CMC Mature, Regulatory Affairs

Key skills