Director, Regulatory Affairs

About us:

Our purpose at Dispatch is to help create a world where all cancer patients can be cured. We’re humbled by the opportunity to work together as a team on some of the most pressing medical challenges of our time. 

To achieve our purpose, we are dedicated to engineering a universal treatment across solid tumors. We’re committed to the development of novel therapies, leveraging first-in-class technologies in viral vectors, universal targets, and novel cytokine biology. Our therapeutic approach has the potential to enable us to treat significant numbers of cancer patients and make a real and lasting impact on the world. 

Our company was founded on pioneering work carried out in the laboratories of 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).

At our company, you would become one of our early team members— not only playing a role in meeting our ambitious mission but also building our thriving culture.  We are determined to deliver with urgency to discover new solutions and we always stay dedicated to scientific rigor; we have an ownership mindset because each and every one of us is integral to our success.  Collaboration is core for us because we believe that by bringing people together with diverse perspectives, we make a stronger whole.  And, we show we care about our work and each other by sharing feedback - ultimately in service of our vision to empower people to continue forward with their lives – cancer free. 

The role:

The Director/Executive Director, Regulatory CMC will lead regulatory CMC strategy and execution for our cell and gene therapy pipeline and will report directly to the Vice President, Head of Regulatory Affairs. This role is both strategic and hands-on, and will be responsible for the full breadth of CMC regulatory activities across global development programs, from early through late-stage development.

This individual will serve as the primary regulatory CMC point of contact for health authority interactions, author and oversee CMC content for regulatory submissions, and provide regulatory guidance on manufacturing, process, and analytical strategy. This role will work cross-functionally with Process Development, Manufacturing, Analytical Development, Quality, Supply Chain, Clinical Development, and external partners such as CDMOs and testing laboratories.

Key responsibilities:

• Lead the development and execution of global regulatory CMC strategies 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