Senior Associate/Manager, Regulatory Affairs
Dispatch BioPhiladelphia, Pennsylvania, United States · Posted 3 months agoDescription
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 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.
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 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
- Ability to work onsite or in a hybrid setup
- 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:
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.
Determined to deliver:
By working with focus and passion, we can provide patients with the solutions they need.
Own every outcome:
We can reach new heights when we stay centered on our shared success.
Collaboration at the core:
When we band together, our work is better.
Feedback is fundamental:
Constructive and authentic positive feedback may be difficult to master but it is vital to our success.
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.
Similar jobs
Est. 140,000 USD
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.…
Est. 140,000 USD
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.…
Est. 65,000 USD
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.…
Est. 85,000 USD
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.…
Est. 85,000 USD
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.…
Est. 140,000 USD
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.…
Est. 85,000 USD
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.…
Est. 140,000 USD
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.…
Est. 120,000 USD
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.…
Est. 120,000 USD
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.…
Est. 150,000 USD
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating…
Est. 85,000 USD
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.…
Est. 258,000 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 182,500 USD
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating…
Est. 207,500 USD
Syndax Pharmaceuticals is looking for an Associate Director, Regulatory Strategy At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceutical…
Est. 210,000 USD
Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However,…
Est. 130,000 USD
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating…
Est. 150,000 USD
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating…
Est. 327,641 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 235,000 USD
Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However,…
Est. 228,000 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 188,500 USD
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Est. 237,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 237,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 200,000 USD
About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatme…
Est. 150,000 USD
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating…
Est. 237,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 209,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 327,641 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 312,500 USD
About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and i…