Sr. Dir., Regulatory & Assc. General Counsel Remote (anywhere in United States)

DEPARTMENT: Regulatory Affairs

LOCATION: Durham, NC, Fully Remote

COMPANY: 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 [.

JOB SUMMARY:

The Senior Director Commercial Regulatory Affairs & Associate General Counsel serves as the primary legal and commercial regulatory advisor supporting the commercialization of SYMVESS. This position has dual accountability for providing legal counsel to Commercial Operations and serving as the Regulatory Affairs representative for advertising, promotion, and product communications.

This individual serves as both the Legal and Regulatory Affairs representative on the Medical-Legal-Regulatory (MLR)/Promotional Review Committee (PRC) for SYMVESS and partners closely with Commercial, Medical Affairs, Quality, Regulatory Affairs, Market Access, Sales, Training, Compliance, and senior leadership to enable compliant and effective commercialization.

The role requires the ability to translate complex product labeling, clinical evidence, FDA requirements, and healthcare legal requirements into practical guidance for a specialized commercial organization. The Associate General Counsel is expected to engage early in commercial strategy and provide practical, risk-based solutions rather than functioning solely as a late-stage reviewer.

ESSENTIAL FUNCTIONS:

• Serve as both the Legal and Regulatory Affairs representative on the SYMVESS MLR/PRC and provide review and approval of promotional, educational, digital, market access, training, congress, and field-used materials.
• Evaluate materials for consistency with FDA-approved labeling, claims substantiation, fair balance, risk presentation, material facts, clinical and scientific data, and the distinction between promotional and scientific communications.
• Serve as the commercial Regulatory Affairs subject-matter expert for SYMVESS advertising and promotion, interpreting applicable FDA/CBER requirements, guidance, enforcement actions, and regulatory precedent.
• Oversee or support required FDA submission of promotional materials, including applicable Form FDA 2253 processes.
• Lead development and maintenance of the SYMVESS claims matrix, including standards for approved claims, references, qualifiers, clinical and labeling support, comparative claims, and high-risk or prohibited claims.
• Serve as a strategic legal advisor to Commercial leadership and counsel cross-functional teams on commercialization strategy, healthcare professional interactions, speaker programs, advisory boards, consultant arrangements, congresses, market access, reimbursement communications, digital engagement, patient support, and competitive positioning.
• Provide guidance regarding the Federal Food, Drug, and Cosmetic Act, Anti-Kickback Statute, False Claims Act, Open Payments requirements, applicable state laws, privacy considerations, industry standards, and company policies.
• Provide Legal and Regulatory oversight of training for personnel interacting with vascular surgeons and other healthcare professionals, including approved indication, claims, safety information, unsolicited questions, scientific exchange, competitive discussions, off-label inquiries, and escalation to Medical Affairs.
• Establish practical Legal and Regulatory standards for QR codes, Important Safety Information, digital fair balance, email promotion, text/SMS communications, websites, digital sales materials, congress content, and HCP follow-up communications.
• Lead the SYMVESS MLR/PRC governance framework, including roles and responsibilities, submission standards, timelines, service levels, escalation procedures, substantiation standards, and precedent documentation.
• Identify significant legal and regulatory risks early and develop practical mitigation strategies and compliant alternatives that support timely business decisions.
• Partner with Commercial, Medical Affairs, Clinical, Quality, Regulatory Affairs, Compliance, Market Access, Finance, Corporate Communications, and executive leadership.
• Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Juris Doctor (J.D.) from an accredited law school.
• Active membership in good standing with at least one U.S. state bar.
• Typically 10+ years of relevant pharmaceutical, biotechnology, FDA regulatory, healthcare, or life sciences legal experience, with level determined by depth and breadth of experience.
• Significant experience with prescription drug and/or biologic advertising and promotion and demonstrated experience serving on or advising an MLR/PRC or comparable promotional review committee.
• Demonstrated ability to independently perform both Legal and Commercial Regulatory review of promotional materials and activities.
• Strong working knowledge of FDA advertising and promotion requirements, healthcare fraud and abuse laws, and the regulatory framework applicable to prescription products.
• Experience counseling Commercial organizations on pharmaceutical or biotechnology commercialization activities.
• Ability to assess complex legal and regulatory issues, exercise independent judgment, distinguish material risk from theoretical risk, and communicate practical recommendations to senior business leaders.
• In-house pharmaceutical or biotechnology experience and experience supporting FDA-regulated biologics and/or CBER-regulated products preferred.
• Experience supporting product launch, specialty products used by specialist physicians or surgeons, promotional claims matrices, Form FDA 2253 processes, Veeva Vault PromoMats or a comparable platform, and digital or omnichannel promotion preferred.
• Strong written, verbal, negotiation, interpersonal, and cross-functional leadership skills.
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
• Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross-functional teams.
• Excellent organizational and time management skills with the ability to set priorities in a timely manner.
• High degree of flexibility and adaptability.
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
• Represents the organization in a positive and highly professional manner.

COMPENSATION & BENEFITS HIGHLIGHTS:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

The 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.