{"id":849783,"url":"https://alion.io/job/dispatchbio-executive-director-regulatory-affairs-cmc","title":"(Executive) Director, Regulatory Affairs, CMC","company":{"id":673610,"name":"Dispatch Bio","domain":"dispatchbio.com","url":"https://alion.io/company/dispatchbio","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Philadelphia, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":250000,"max":325000,"currency":"USD","period":"year","gross":null,"usd_annual":325000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-21T02:21:43Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-27T13:01:32Z","board_verified":true,"closed_at":null,"days_open":67,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":67},"description":"About us:\nOur 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. \nTo 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. \nOur 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).\nAt 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. \nThe role:\nThe Director/Executive Director, Regulatory CMC will lead regulatory CMC strategy and execution for our cell and gene therapy pipeline and will report directly to the Vice President, Head of Regulatory Affairs. This role is both strategic and hands-on, and will be responsible for the full breadth of CMC regulatory activities across global development programs, from early through late-stage development.\nThis individual will serve as the primary regulatory CMC point of contact for health authority interactions, author and oversee CMC content for regulatory submissions, and provide regulatory guidance on manufacturing, process, and analytical strategy. This role will work cross-functionally with Process Development, Manufacturing, Analytical Development, Quality, Supply Chain, Clinical Development, and external partners such as CDMOs and testing laboratories.\nKey responsibilities:\nLead the development and execution of global regulatory CMC strategies Dispatch programs, from early development through licensure\nAuthor, review, and approve CMC sections of regulatory submissions, including INDs, CTAs, BLAs/MAAs, amendments, annual reports, and responses to health authority questions\nServe as the primary regulatory CMC liaison to health authorities (e.g., FDA, EMA, TGA), leading preparation for and participation in CMC-focused meetings and other health authority interactions\nPartner closely with Process Development, Manufacturing, Analytical Development, and Quality to ensure regulatory compliance and submission readiness across the product lifecycle\nProvide strategic regulatory guidance on manufacturing changes, process validation, comparability protocols, and facility qualification/licensure activities\nAssess regulatory risk associated with CMC and manufacturing decisions, and advise senior leadership on mitigation strategies and health authority engagement\nTrack, interpret, and communicate evolving global CMC regulatory guidance and policy trends relevant to cell and gene therapy manufacturing\nManage regulatory CMC aspects of relationships with CDMOs, contract testing laboratories, and other external manufacturing partners\nBuild, mentor, and develop regulatory CMC talent as the team and pipeline grow\nContribute to and help scale regulatory CMC processes, tools, and templates appropriate for a growing organization\nRepresent Regulatory CMC on cross-functional program teams and provide regular updates to senior leadership\nRequired experience & skills:\nBachelor's degree in life sciences, chemistry, engineering, or a related discipline\nMinimum of 10 years of regulatory CMC experience within the biotechnology or pharmaceutical industry\nDirect, hands-on experience authoring and managing CMC sections of IND, BLA, or MAA submissions\nDirect experience with cell therapy, viral vector, or other advanced therapy medicinal product (ATMP) manufacturing\nDeep working knowledge of FDA and ICH CMC regulations and guidelines applicable to biologics; cell and/or gene therapy experience\nDemonstrated experience leading CMC-focused health authority interactions and correspondence\nTrack record managing complex manufacturing regulatory strategy, including comparability assessments and post-approval/process changes\nAbility to work onsite or in a hybrid setup\nStrong leadership skills with the ability to influence and align cross-functional stakeholders without direct authority\nExcellent written and verbal communication skills, with strong attention to detail\nAbility to operate effectively and independently in a fast-moving, resource-constrained startup environment\nPreferred experience & skills: \nAdvanced degree (MS, PhD, PharmD)\nExperience with global CMC regulatory submissions (e.g., EMA or other ex-U.S. agencies)\nPrior experience supporting solid tumor drug development\nPeople management experience, with a track record of developing regulatory talent\n #LI-DNI\nBase Salary Range: $250-325K\nOur values: \nOur 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.\nDetermined to deliver: \nBy working with focus and passion, we can provide patients with the solutions they need. \nOwn every outcome: \nWe can reach new heights when we stay centered on our shared success. \nCollaboration at the core: \nWhen we band together, our work is better. \nFeedback is fundamental: \nConstructive and authentic positive feedback may be difficult to master but it is vital to our success. \n\nWorking here:\nWe offer a highly competitive compensation package with meaningful ownership through equity\nExcellent coverage for medical, vision, and dental\n401(k) with generous contribution\nLife insurance\nFlexible PTO policy\nAdditional substantial benefits\nWe are an equal opportunity employer. \nWe 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.","description_format":"text","description_chars":6650,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Life insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-13T02:56:38Z"}],"visa":[],"liveness":{"score":48,"band":"ok","label":"Likely open","p_open":1,"p_active":0.804,"p_room":0.6,"age_days":67,"expected_fill_days":77,"reasons":["conf:1","win:late","crowd:"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":325000,"is_top_pay":true},"html_url":"https://alion.io/job/dispatchbio-executive-director-regulatory-affairs-cmc","json_url":"https://alion.io/job/dispatchbio-executive-director-regulatory-affairs-cmc.json","meta":{"generated_at":"2026-10-27T14:39:13Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":3290,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":673610},"rest":"https://alion.io/mcp/rest/get_company?id=673610"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fdispatchbio-executive-director-regulatory-affairs-cmc"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fdispatchbio-executive-director-regulatory-affairs-cmc"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fdispatchbio-executive-director-regulatory-affairs-cmc"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/dispatchbio-executive-director-regulatory-affairs-cmc\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fdispatchbio-executive-director-regulatory-affairs-cmc"}]}