We are seeking a highly experienced Senior Vice President, CMC Regulatory Affairs to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. This role is designed for a recognized subject matter expert in CMC Regulatory Affairs, with deep experience navigating FDA, EMA, and global health authority interactions for biologics and complex modalities.
The SVP will serve as the primary CMC regulatory authority within the organization, shaping regulatory strategy from early development through commercialization, leading global submissions, and acting as the senior point of contact with health authorities. This role is critical to enabling efficient development, successful approvals, and long-term lifecycle management.
Key Responsibilities
- Define and lead the global CMC regulatory strategy across all development stages, from IND/IMPD through BLA/MAA and post-approval lifecycle management.
- Serve as the primary CMC regulatory interface with FDA, EMA, and other global health authorities, including leading Type B/C, EOP, pre-BLA/MAA, and scientific advice meetings.
- Provide expert regulatory guidance on CMC requirements, risk assessment, and mitigation strategies for biologics and complex modalities.
- Oversee the authoring, review, and approval of CMC sections (Modules 2 and 3) for regulatory submissions, ensuring accuracy, consistency, and compliance with global requirements.
- Lead regulatory responses to health authority questions, information requests, and inspection findings related to CMC.
- Partner closely with CMC, Manufacturing, Analytical, Quality, and Supply Chain teams to ensure regulatory alignment with development and manufacturing strategies.
- Guide CMC regulatory strategy for CDMO selection, tech transfer, site changes, and post-approval changes, including comparability and change management.
- Establish and maintain regulatory intelligence capabilities, monitoring evolving global regulations, guidance, and expectations impacting CMC.
- Build, lead, and mentor a high-performing CMC Regulatory Affairs organization, fostering scientific rigor, accountability, and collaboration.
- Represent CMC Regulatory Affairs at the executive leadership level, providing clear recommendations, risk assessments, and decision support.
Qualifications & Experience
- Ph.D., M.S., or equivalent advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related discipline.
- 15+ years of progressive experience in CMC Regulatory Affairs, with significant experience at the senior or executive level.
- Demonstrated success leading global CMC regulatory strategy for biologics; experience with ADCs, cell and gene therapies, or combination products is strongly preferred.
- Extensive experience managing FDA and EMA interactions, including leading formal meetings and negotiations.
- Deep knowledge of ICH guidelines, FDA regulations, and global CMC regulatory requirements.
- Proven track record of successful INDs, BLAs, MAAs, and post-approval change submissions.
- Experience working with external CDMOs and advising on regulatory implications of manufacturing and supply chain strategies.
- Exceptional leadership, communication, and influencing skills, with the ability to operate effectively at the executive level.
- Ability to thrive in a fast-paced, SME environment with multiple concurrent programs.
What We Offer
- Opportunity to shape CMC regulatory strategy for innovative therapies with significant patient impact.
- Executive visibility and influence within a growing, science-driven organization.
- Competitive executive compensation, including base salary, bonus, and long-term incentives.
- Comprehensive benefits and flexible work arrangements.