Director, Regulatory Affairs

DEPARTMENT:Regulatory Affairs

LOCATION: Headquarters or Remote, East Coast US

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 www.Humacyte.com.

JOB SUMMARY:

The 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.

The 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.

ESSENTIAL FUNCTIONS:

• Serve as the FDA point of contact for assigned development programs and coordinate regulatory communications.
• Co-lead cross-functional Biologics License Application (BLA) submission efforts, coordinating contributions and timelines across functions.
• Serve as regulatory strategist and regulatory project lead or co-lead for assigned projects.
• Develop and implement U.S. and global regulatory strategies for assigned projects.
• Serve as subject matter expert for clinical modules in regulatory filings.
• Monitor and interpret new policies and guidance from FDA and other health authorities and assess their impact on assigned programs and company business.
• As assigned, serve as global regulatory lead, coordinating document preparation and interactions with other health authorities.
• Coach and mentor junior staff supporting the Regulatory Affairs team, as needed.

EXPERIENCE & QUALIFICATIONS:

• Graduate degree in a life science; such as Ph.D., M.D., or Pharm.D. highly preferred.
• At least five years of regulatory project lead experience required.
• Recent hands-on experience leading BLA submissions, preferably to FDA’s Center for Biologics Evaluation and Research (CBER).
• Recent experience supporting biologics development.
• Demonstrated experience with successful submission and FDA approval of a BLA or New Drug Application (NDA).
• Experience serving as the point of contact for FDA and other health authorities and leading formal health authority meetings.
• Knowledge of FDA content and technical requirements for BLA submissions.
• Demonstrated experience developing and implementing regulatory strategies for U.S. Investigational New Drug applications (INDs), BLAs, and/or NDAs.
• Ability to lead cross-functional teams, manage submission timelines, and deliver under tight deadlines and high-pressure conditions.
• Basic computer proficiency, including Microsoft Word, Excel, PowerPoint, and Outlook.
• Effective written and verbal communication in English, strong interpersonal skills, and demonstrated cross-functional leadership.
• 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.
• Adhere to company and facility policies and procedures, including SOPs, training, and meeting requirements; maintain required training and certifications.
• Observe safety precautions and regulations and report safety hazards and potentially unsafe working conditions.
• Report to work on time and as scheduled, with availability to meet tight deadlines and peak-period demands.
• 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.

Originally posted on Himalayas