[Hiring] Senior Director, Regulatory Affairs & Associate General Counsel @Humacyte

Role Description

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 various departments 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.
• 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 various departments including Commercial, Medical Affairs, Clinical, Quality, Regulatory Affairs, Compliance, Market Access, Finance, Corporate Communications, and executive leadership.
• Other duties as assigned.

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.
• Significant experience with prescription drug and/or biologic advertising and promotion.
• 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, and communicate practical recommendations to senior business leaders.
• In-house pharmaceutical or biotechnology experience preferred.
• Experience supporting product launch, specialty products, promotional claims matrices, 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.
• Excellent organizational and time management skills.
• 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.

Benefits

• 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