Senior Associate, Regulatory Affairs

Dispatch Bio • Philadelphia, PA

2d

About The Position

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.

Requirements

• Bachelor’s degree in life sciences or related discipline
• Minimum of 2 years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry
• 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

Nice To Haves

• 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

Responsibilities

• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level