{"id":3619056,"url":"https://alion.io/job/humacyte-director-regulatory-affairs","title":"Director, Regulatory Affairs","company":{"id":2472022,"name":"Humacyte","domain":"humacyte.com","url":"https://alion.io/company/humacyte","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Durham, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-11-02T17:39:46Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-05T05:15:04Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"DEPARTMENT: Regulatory Affairs\nLOCATION: Headquarters or Remote, East Coast US\nCOMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com.\nJOB SUMMARY:\nThe Director of Regulatory Affairs is a key member of the Regulatory Affairs team, reporting to the Chief Regulatory Officer. This position serves as Humacyte’s liaison to the U.S. Food and Drug Administration (FDA) for assigned projects in clinical development.\nThe Director functions as Regulatory Lead and partners with multidisciplinary, matrixed project teams to meet project deliverables while adhering to regulatory requirements for development programs and products. This role develops and executes regulatory strategies for products in early- and late-stage development and leads or co-leads assigned regulatory projects and submission activities.\nESSENTIAL FUNCTIONS:\nServe as the FDA point of contact for assigned development programs and coordinate regulatory communications.\nCo-lead cross-functional Biologics License Application (BLA) submission efforts, coordinating contributions and timelines across functions.\nServe as regulatory strategist and regulatory project lead or co-lead for assigned projects.\nDevelop and implement U.S. and global regulatory strategies for assigned projects.\nServe as subject matter expert for clinical modules in regulatory filings.\nMonitor and interpret new policies and guidance from FDA and other health authorities and assess their impact on assigned programs and company business.\nAs assigned, serve as global regulatory lead, coordinating document preparation and interactions with other health authorities.\nCoach and mentor junior staff supporting the Regulatory Affairs team, as needed.\nEXPERIENCE & QUALIFICATIONS:\nGraduate degree in a life science; such as Ph.D., M.D., or Pharm.D. highly preferred.\nAt least five years of regulatory project lead experience required.\nRecent hands-on experience leading BLA submissions, preferably to FDA’s Center for Biologics Evaluation and Research (CBER).\nRecent experience supporting biologics development.\nDemonstrated experience with successful submission and FDA approval of a BLA or New Drug Application (NDA).\nExperience serving as the point of contact for FDA and other health authorities and leading formal health authority meetings.\nKnowledge of FDA content and technical requirements for BLA submissions.\nDemonstrated experience developing and implementing regulatory strategies for U.S. Investigational New Drug applications (INDs), BLAs, and/or NDAs.\nAbility to lead cross-functional teams, manage submission timelines, and deliver under tight deadlines and high-pressure conditions.\nBasic computer proficiency, including Microsoft Word, Excel, PowerPoint, and Outlook.\nEffective written and verbal communication in English, strong interpersonal skills, and demonstrated cross-functional leadership.\nPossess a positive roll-up-the-sleeves attitude and optimistic outlook.\nStrong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross-functional teams.\nExcellent organizational and time management skills with the ability to set priorities in a timely manner.\nHigh degree of flexibility and adaptability.\nSelf-motivated and organized critical thinker with solid interpersonal and business communication skills.\nAdhere to company and facility policies and procedures, including SOPs, training, and meeting requirements; maintain required training and certifications.\nObserve safety precautions and regulations and report safety hazards and potentially unsafe working conditions.\nReport to work on time and as scheduled, with availability to meet tight deadlines and peak-period demands.\nRepresents the organization in a positive and highly professional manner.\nCOMPENSATION & BENEFITS HIGHLIGHTS:\nStock Options\n401k Plan with 4% Match and no Vesting Schedule\nMedical, Vision and Dental Plans\nCompany Paid Long Term/Short Term Disability\nCompany Paid Life Insurance\n23 Days Paid Time Off (PTO)\n10 Company Designated Holidays + 2 Floating Holidays\nPaid Parental Leave Policies\n** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **\nThe statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.","description_format":"text","description_chars":6240,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":["401k plan","Life insurance","Parental leave","Stock options"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Regenerative Medicine"],"lifecycle":[{"event":"open","at":"2026-11-02T17:39:46Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":41,"reasons":["conf:0","win:early"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/humacyte-director-regulatory-affairs","json_url":"https://alion.io/job/humacyte-director-regulatory-affairs.json","meta":{"generated_at":"2026-11-05T10:56:51Z","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":14080,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":2472022},"rest":"https://alion.io/mcp/rest/get_company?id=2472022"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhumacyte-director-regulatory-affairs"},{"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%2Fhumacyte-director-regulatory-affairs"},{"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%2Fhumacyte-director-regulatory-affairs"},{"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/humacyte-director-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhumacyte-director-regulatory-affairs"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3619056}},{"tool":"search_jobs","arguments":{"company":"humacyte.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3619056},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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