[Hiring] Director, Regulatory Affairs @Humacyte

Role Description

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.

• 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.

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.

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