Senior Associate/Manager, Regulatory Affairs

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 Senior Associate/Manager, Regulatory Affairs will be a key individual contributor on a small, high-impact regulatory team and will report directly to the Vice President, Head of Regulatory Affairs. This role is highly hands-on and will support the full breadth of regulatory activities across global development programs.

The Senior Associate/Manager will play a critical role in shaping regulatory strategy, authoring and managing regulatory documents, supporting regulatory operations, and keeping the teams up to date on regulatory landscape. This individual will work cross-functionally with Clinical Development, CMC, Quality, Research, and external partners such as CROs, Medical Writers and Regulatory Operations.

Author, review, and manage technically complex regulatory submissions, including investigational new drug applications (IND), amendments, meeting briefing packages, annual reports, and responses to health authority questions for our DISP-10 program in solid tumors

Serve as a regulatory core team member on study teams, providing guidance to cross-functional stakeholders on regulatory requirements and risks

Support health authority interactions (e.g., FDA, TGA), including preparation for and participation in meetings and other health authority interactions

Manage regulatory operations activities, including preparing document submissions, submission planning, and maintenance of regulatory archives

Contribute to and execute global regulatory strategies for our lead asset from early development through clinical stages

Track, assess, and communicate relevant regulatory intelligence, guidance, and policy trends impacting oncology and cell therapy development

Support interactions with external partners, including CROs and regulatory vendors, ensuring alignment with regulatory strategy and timelines

Ensure regulatory activities are compliant with applicable regulations, guidelines, and internal processes

Contribute to continuous improvement of regulatory processes, tools, and templates appropriate for a growing organization

Bachelor’s degree in life sciences or related discipline

Minimum of 2 years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry for Senior Associate level

Minimum of 5 years of Regulatory Affairs experience within the bio/pharma industry for Manager level

Direct experience supporting oncology drug development, including IND-stage programs

Ability to independently drive projects while knowing when to escalate or seek alignment

Hands-on experience authoring and managing regulatory submissions and health authority correspondence

Strong understanding of FDA regulations and ICH guidelines relevant to clinical-stage development

Excellent written and verbal communication skills, with strong attention-to-detail

Highly organized, with the ability to manage multiple priorities in a fast-moving environment

Collaborative, proactive, and comfortable operating in a small, resource-constrained startup setting

Preferred experience & skills:

Advanced degree (MS, PHD, PharmD)

Prior experience with cell therapy or advanced therapy medicinal products (ATMPs)

Experience working in early-stage or startup biotech environments

Direct experience supporting solid tumor drug development

Direct experience preparing original IND submissions

Exposure to global regulatory development (e.g., EMA or other ex-U.S. agencies)

Experience supporting regulatory aspects of CMC and manufacturing activities for cell therapies

Our values guide everything we do. While capabilities and skills are vital, understanding how a potential new colleague would embody our values is central to our hiring decisions.

By working with focus and passion, we can provide patients with the solutions they need.

We can reach new heights when we stay centered on our shared success.

When we band together, our work is better.

Constructive and authentic positive feedback may be difficult to master but it is vital to our success.

We offer a 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

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.