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Dispatch is a cell and gene therapy company founded on pioneering work from leading cancer researchers at UPenn, UCSF, Stanford, and Memorial Sloan Kettering. The company is developing novel therapies targeting solid tumors using first-in-class viral vector and cytokine biology technologies.
The Director of Regulatory Affairs, CMC will lead the regulatory chemistry, manufacturing, and controls (CMC) strategy and execution across Dispatch's cell and gene therapy pipeline. Reporting to the VP of Regulatory Affairs, this role combines strategic oversight with hands-on regulatory work, spanning early-stage development through commercial licensure.
Key responsibilities include: developing and executing global CMC regulatory strategies; authoring and overseeing CMC sections of regulatory submissions (INDs, CTAs, BLAs/MAAs, amendments, annual reports, and health authority responses); serving as the primary CMC liaison to regulatory agencies (FDA, EMA, TGA); leading CMC-focused health authority meetings and interactions; partnering with Process Development, Manufacturing, Analytical Development, Quality, and Supply Chain teams to ensure regulatory compliance and submission readiness; providing strategic guidance on manufacturing changes, process validation, comparability protocols, and facility qualification; assessing and mitigating CMC regulatory risks; tracking evolving global CMC guidance relevant to cell and gene therapies; managing regulatory aspects of CDMO and contract testing laboratory relationships; building and mentoring regulatory CMC talent; scaling regulatory processes and templates; and representing CMC on cross-functional program teams.
Required qualifications: Bachelor's degree in life sciences, chemistry, engineering, or related discipline; minimum 10 years of regulatory CMC experience in biotech or pharma; direct hands-on experience authoring and managing CMC sections of IND, BLA, or MAA submissions; direct experience with cell therapy, viral vector, or advanced therapy medicinal product (ATMP) manufacturing; deep knowledge of FDA and ICH CMC regulations and guidelines for biologics, cell therapy, and gene therapy; demonstrated experience leading CMC health authority interactions; track record managing complex manufacturing regulatory strategy including comparability assessments and post-approval changes; strong leadership and cross-functional influence skills; and excellent written and verbal communication abilities.
