Senior Associate, Regulatory Affairs
Dispatch Bio
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, 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:
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 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.
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, 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
- 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
- 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
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 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.
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Associate, Regulatory Affairs in Philadelphia, PA vacancy
- ..., we strongly encourage you to apply directly through our website. For all virtual remote positions, in order to ensure associates can effectively perform their job duties with no distractions, we require an uninterrupted virtual work space and there is also an...SeniorLocal areaRemote work
- Susquehanna International Group is seeking a Senior Compliance Officer in Bala Cynwyd, PA to provide regulatory guidance for equities trading teams. The role involves ensuring compliance with regulations, collaborating with stakeholders, and advising on market conduct....Senior
- Overview We are seeking a highly motivated individual to join our team as a Senior Fixed Income Compliance Officer. In this role the individual will provide real‑time regulatory guidance and oversight to the firm’s fixed income trading and sales teams. The role ensures...Senior
- Ascensus is seeking a Compliance Testing Analyst in Montgomery County to perform compliance testing for retirement plans. The role requires at least 8 years of plan administration experience and involves ensuring tax compliance and quality control on financial activities...Senior
- ...Sr. Regulatory Specialist The Sr. Regulatory Specialist is responsible for supporting client product and product development and regulatory... ...authorities. Responsibilities: Represent Regulatory Affairs on cross functional project teams and provide strategic input...Senior
- ...work out of our Charlotte, NC location on a Hybrid work schedule. In this role, you will impact Honeywell's ability to maintain regulatory compliance, mitigate risks related to integrity and ethics, and support the company's reputation as a responsible and trusted...SeniorTemporary workFor contractorsWorldwideFlexible hours
- ...Senior P&C Consulting Actuary opening in New York City or Philadelphia. Design solutions involving reserving and pricing for clients in (re)insurance companies, self-insured corporations, and captives. Ideal candidate is ACAS or FCAS with 5+ years of P&C actuarial insurance...Senior
- Mentor Behavioral Health , a part of the Sevita family, provides Early Intervention, Applied Behavioral Analysis (ABA) and Behavioral Health services to children, individuals and families. Here we believe every person has the right to live well, and everyone deserves...Full timeContract workFlexible hours
- ...colleagues and staff, provides daily instruction to patients including for home exercise programs. Ensures compliance/assists in regulatory preparation in clinical space. Performs other duties as assigned. Contributes to a safe and therapeutic environment that is centered...SeniorPart time
- ...Cyber Identity - Ping Senior Consultant Engineering and Product | Engineering Management Arlington/Rosslyn, Virginia, United States Atlanta, Georgia, United States Austin, Texas, United States Baltimore, Maryland, United States Boston, Massachusetts,...Senior
- Join Lockheed Martin, a leader in the Defense & Aerospace industry, where innovation, ethics, and teamwork are valued. As a Senior Software Engineer Staff in our IT & Cybersecurity department, you will contribute to cutting-edge projects that reinforce national security...Senior
- ...Senior Vice President, Divisional Lead, Property and Casualty Insurance About the Company Top-tier insurance agency Industry Insurance Type Privately Held About the Role The Company is seeking a Senior Vice President, Divisional Lead for Property...Senior
- ...Senior Sap Test Manager Location – Philadelphia, PA (Hybrid) Start date for assignment is 1st April 2024 Rate: DOE Roles & Responsibilities Senior SAP Test Manager in US reporting to the UAT test manager at UK Experience with SAP Modules like S2P, R2...Senior
- ...Senior Manager - Cloud Architect Strategy, Growth, and Transformation | Enterprise Technology Strategy and Transformation Atlanta, Georgia, United States Boston, Massachusetts, United States Charlotte, North Carolina, United States Chicago, Illinois, United...Senior
- OfficeTeam - JobID: 03720-0013424494-usen [ Office Team by Robert Half leverages its strong relationships with hiring managers across the globe to not only help you find work, but also coach you through the interview process and provide long-term resources to you while...SeniorWork at office
- ...Senior Director Clinical Operations About the Company Fast-growing biotechnology (BioTech) organization Industry Biotechnology Type Privately Held About the Role The Senior Director Clinical Operations will be responsible for spearheading the operational...Senior
- ...Senior Data Scientist As a Senior Data Scientist, you will apply expert knowledge of data science and quantitative analytical methods to organize, analyze, interpret, and derive meaningful insight from structured and unstructured data in support of real-world problem...SeniorWork at office
- ...Architect Senior ServiceNow Developer Location: Philadelphia, PA/ Mount Laurel, NJ 08054 Duration: 6+ Months Experience in SPM (Strategic Portfolio Management) functional and technical Should be well versed with all the modules like - Strategic Planning, Scenario...Senior
- ...Overview of Role: The Network Architect (Senior) is responsible for developing detailed technical network designs for Department of Defense campus network modernization programs. This role translates high-level architectural concepts into implementable engineering...Senior
- ...Senior HPE NonStop Systems Administrator The Senior HPE NonStop Systems Administrator plays a mission-critical role in supporting and maintaining high-availability HPE NonStop (Tandem) platforms that underpin Amtrak’s real-time train dispatching systems. Based in Philadelphia...Senior
- ...boutique actuarial consulting firm that specializes in pension and health plans in the multiemployer space. They are looking for a Senior Consultant who can serve as the day-to-day contact for 8 - 10 pension clients. Multiemployer experience is a plus, but they are open...Senior
- ...Be a part of a dynamic team at Senior Community Services. Do you want to make a difference in the older adults’ lives in your community? Our Good Neighbor Center located in Sharon Hill is in need of Meal Drivers and Runners. We deliver meals to homebound older adults...SeniorDay shift
- ...We are a personal care home for senior women located in Roxborough, PA. We are actively seeking an exercise coach to come in once a week and teach a senior-friendly exercise class for our residents (light pilates, chair aerobics etc.) We welcome professionals willing...Senior1 day per week
- Job Description Job Description Description: Serve as NAVSEA 05R Reprocurement Execution Coordinator. Represents Maritime Navy during Engineering Support negotiations (Navy/DLA Performance Based Agreement (PBA); NAVSEA/NAVSUP Engineering Support Instruction and PBA...Senior
- ...Senior.NET Developer Opportunity We are looking for a Senior.NET Developer opportunity in Plymouth Meeting, PA. Must be on East Coast Description: Sr. Software Engineer opening Microsoft stack / umbrella .Net core, angular This need is Sr. .Net...Senior
- QA experience for Java (is a must) and Python (is a must) Cucumber (is a must) Testing Restful API's (is a must) Should have worked with github (is a must) Integrating test cases with Jenkins. (good to have) Any performance testing tools like jmeter...Senior
- Schneider Electric - - Responsibilities: Perform assembly, startup, diagnostic, repair and preventive maintenance on company and third-party equipment; Travel throughout the region for local or countrywide travel; Complete field service reports and expense reports; Work...SeniorLocal area
- ...Senior Cath Lab Tech RN/LPN Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission...SeniorShift workWeekend work1 day per week
- ...Senior Voice Engineer - designing, deploying, and supporting Unified Communications platform Technical Skills ~ i. Deep understanding of voice protocols and applications such as SIP, RTP, SDP, and TLS ii. Strong Linux expertise, including scripting...Senior
- Job Title Location: Alpharetta, GA; Charlotte, NC; Chicago, IL; Colorado Springs, CO; Conshohocken, PA; Dallas, TX; Denver, CO; Fargo, ND; Garden City, NY; Houston, TX; Jacksonville, IL; Lenexa, KS; Los Angeles, CA; Lubbock, TX; Morristown, NJ; Mt Juliet, TN; New York...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Associate, Regulatory Affairs. Be the first to apply!
Related searches
- information security compliance analyst Philadelphia, PA
- compliance associate Philadelphia, PA
- compliance analyst Philadelphia, PA
- cybersecurity policy and compliance analyst Philadelphia, PA
- regulatory officer Philadelphia, PA
- coding compliance specialist Philadelphia, PA
- compliance consultant Philadelphia, PA
- risk and compliance analyst Philadelphia, PA
- regulatory affairs consultant Philadelphia, PA
- healthcare compliance officer Philadelphia, PA


