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About the Role

Lead regulatory CMC strategy and execution for a cell and gene therapy pipeline, managing CMC regulatory activities across global development programs from early to late-stage. Serve as the primary regulatory CMC point of contact for health authorities, authoring and overseeing CMC content for regulatory submissions, and providing guidance on manufacturing, process, and analytical strategy.

Responsibilities

• Lead the development and execution of global regulatory CMC strategies for Dispatch programs, from early development through licensure.
• Author, review, and approve CMC sections of regulatory submissions, including INDs, CTAs, BLAs/MAAs, amendments, annual reports, and responses to health authority questions.
• Serve as the primary regulatory CMC liaison to health authorities (e.g., FDA, EMA, TGA), leading preparation for and participation in CMC-focused meetings and other health authority interactions.
• Partner closely with Process Development, Manufacturing, Analytical Development, and Quality to ensure regulatory compliance and submission readiness across the product lifecycle.
• Provide strategic regulatory guidance on manufacturing changes, process validation, comparability protocols, and facility qualification/licensure activities.
• Assess regulatory risk associated with CMC and manufacturing decisions, and advise senior leadership on mitigation strategies and health authority engagement.
• Track, interpret, and communicate evolving global CMC regulatory guidance and policy trends relevant to cell and gene therapy manufacturing.
• Manage regulatory CMC aspects of relationships with CDMOs, contract testing laboratories, and other external manufacturing partners.
• Build, mentor, and develop regulatory CMC talent as the team and pipeline grow.
• Contribute to and help scale regulatory CMC processes, tools, and templates appropriate for a growing organization.
• Represent Regulatory CMC on cross-functional program teams and provide regular updates to senior leadership.

Requirements

• Bachelor's degree in life sciences, chemistry, engineering, or a related discipline.
• Minimum of 10 years of regulatory CMC experience within the biotechnology or pharmaceutical industry.
• Direct, hands-on experience authoring and managing CMC sections of IND, BLA, or MAA submissions.
• Direct experience with cell therapy, viral vector, or other advanced therapy medicinal product (ATMP) manufacturing.
• Deep working knowledge of FDA and ICH CMC regulations and guidelines applicable to biologics; cell and/or gene therapy experience.
• Demonstrated experience leading CMC-focused health authority interactions and correspondence.
• Track record managing complex manufacturing regulatory strategy, including comparability assessments and post-approval/process changes.
• Strong leadership skills with the ability to influence and align cross-functional stakeholders without direct authority.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to operate effectively and independently in a fast-moving, resource-constrained startup environment.

Skills

• Regulatory CMC strategy
• CMC regulatory activities
• Health authority interactions
• Regulatory submissions (INDs, CTAs, BLAs/MAAs)
• Manufacturing process guidance
• Analytical strategy guidance
• Cross-functional collaboration
• Risk assessment
• Regulatory compliance
• Process validation
• Comparability protocols
• Facility qualification/licensure
• CDMO management
• Talent development
• Process scaling
• Cell therapy
• Viral vector manufacturing
• Advanced therapy medicinal product (ATMP) manufacturing
• FDA regulations
• ICH guidelines
• Global CMC regulatory submissions
• Solid tumor drug development

Experience Level

• Minimum of 10 years of regulatory CMC experience

Education Level

• Bachelor's degree in life sciences, chemistry, engineering, or a related discipline
• Advanced degree (MS, PhD, PharmD)

Benefits

• Highly competitive compensation package with meaningful ownership through equity
• Excellent coverage for medical, vision, and dental
• 401(k) with generous contribution
• Life insurance
• Flexible PTO policy
• Additional substantial benefits

About the Company

• Our purpose at Dispatch is to help create a world where all cancer patients can be cured.
• Dedicated to engineering a universal treatment across solid tumors, leveraging first-in-class technologies in viral vectors, universal targets, and novel cytokine biology.
• Founded on pioneering work from Dr. Carl June (University of Pennsylvania), Dr. Kole Roybal (University of California, San Francisco), Dr. Christopher Garcia (Stanford University) and Dr. Andy Minn (Memorial Sloan Kettering Cancer Center).
• An early-stage team focused on meeting ambitious missions and building a thriving culture.
• Determined to deliver with urgency, dedicated to scientific rigor, and possess an ownership mindset.
• Values collaboration, believing diverse perspectives create a stronger whole.
• Prioritizes sharing feedback to foster growth and achieve the vision of empowering people to live cancer-free.

Equal Opportunity

• We are an equal opportunity employer.
• We do not discriminate on the basis of race, religion, gender, sexual orientation, age, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.