Senior Associate/Manager, Regulatory Affairs

Dispatch Bio; Philadelphia (Philadelphia County); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation package

Medical, vision, and dental coverage

401(k) with generous contribution

Life insurance

Flexible PTO policy

Additional substantial benefits

Job summary

Dispatch Bio in Philadelphia is seeking a Senior Associate for Regulatory Affairs to support global development programs. This role includes authoring and managing IND submissions, engaging with health authorities, and shaping regulatory strategies. Ideal candidates will have a Bachelor's degree in life sciences and at least 2 years of relevant experience. The position offers a competitive compensation package including medical benefits, a 401(k) plan, and flexible PTO.

Qualifications

• Minimum of 2 years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry.
• Hands-on experience authoring and managing regulatory submissions and health authority correspondence.
• Strong understanding of FDA regulations and ICH guidelines.

Responsibilities

• Author and manage regulatory submissions including IND applications.
• Serve as a regulatory core team member on study teams.
• Support health authority interactions including preparation for meetings.

Skills

Regulatory Affairs experience

Knowledge of FDA regulations

Excellent communication skills

Project management

Education

Bachelor’s degree in life sciences

Job description

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).

The role

The Senior Associate, 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 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.

Key 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

Required experience &skills

• Bachelor’s degree in life sciences or related discipline


• Minimum of 2 years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry


• Ability to independently drive projects while knowing when to elevate 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 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

Working here

• 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.