Director, Regulatory Affairs — FDA Strategy & BLA Lead

Humacyte Global Inc; Durham (NC); Remote; USD 190,000 - 230,000; Full time

Benefits offered by this job

Stock options

401k with match

Medical, Vision and Dental plans

Company paid disability and life保险

Job summary

Humacyte Inc. seeks a Director of Regulatory Affairs to lead regulatory strategies for clinical programs, serving as the liaison to the FDA for assigned projects. The role collaborates with cross-functional teams to ensure compliance and timely submissions, including BLA activities and global regulatory planning.

The position requires senior leadership, strong regulatory expertise in biologics, and the ability to manage timelines under pressure in a fast-paced environment.

Qualifications

• Graduate degree in a life science; PhD/MD/PharmD highly preferred.
• At least five years of regulatory project lead experience.
• Experience leading BLA submissions, preferably to FDA's CBER.
• Experience with FDA approval of BLA/NDA.
• Strong cross-functional leadership and deadline delivery.

Responsibilities

• Serve as the FDA point of contact for assigned development programs.
• Co-lead BLA submissions coordinating contributions and timelines.
• Lead or co-lead regulatory projects and submissions.
• Develop US and global regulatory strategies for assigned programs.
• Mentor junior staff within Regulatory Affairs.

Skills

Regulatory leadership

FDA liaison

Project management

Cross-functional leadership

English communication

Time management

Team mentoring

Biologics knowledge

Education

PhD, MD, or PharmD preferred

Tools

MS Office

Regulatory systems

Job description

Humacyte Inc. seeks a Director of Regulatory Affairs to lead regulatory strategies for clinical programs, serving as the liaison to the FDA for assigned projects. The role collaborates with cross-functional teams to ensure compliance and timely submissions, including BLA activities and global regulatory planning.

The position requires senior leadership, strong regulatory expertise in biologics, and the ability to manage timelines under pressure in a fast-paced environment.