Regulatory Affairs Director — FDA Liaison (Remote/East Coast)

Regulatory Jobs; Durham (NC); Remote; USD 180.000 - 250.000; Vollzeit

Benefits dieser Stelle

Stock Options

401k with 4% match

Medical, Vision and Dental

Disability insurance

Life Insurance

PTO 23 days

Holidays 10 + 2 floating

Parental Leave

Zusammenfassung

Humacyte Inc. is seeking a Director of Regulatory Affairs to serve as the FDA liaison for clinical development programs.

This role leads regulatory strategies for early and late-stage products and may co-lead BLA submissions, coordinating with cross-functional teams to ensure timely regulatory deliverables. The position requires a graduate degree in life sciences with 5+ years of regulatory project leadership, strong experience with BLA submissions (CBER preferred), and excellent communication

Qualifikationen

• Graduate degree in life sciences; PhD/MD/PharmD highly preferred.
• At least five years of regulatory project lead experience.
• Recent hands-on experience leading BLA submissions, preferably to FDA’s CBER.
• Experience supporting biologics development and regulatory filings.
• Demonstrated experience with FDA submissions and approvals (BLA/NDA).
• Strong ability to lead cross-functional teams and meet tight deadlines.

Aufgaben

• Serve as FDA point of contact for assigned development programs and coordinate regulatory communications.
• Co-lead cross-functional BLA submission efforts with timelines across functions.
• Lead/regulatory strategy development and project leadership for assigned programs.
• Develop and implement U.S. and global regulatory strategies for projects.
• Act as SME for regulatory filings and clinical module requirements.
• Monitor FDA guidance and assess impact on programs and company.
• Mentor junior staff on regulatory affairs practices.

Kenntnisse

Regulatory leadership

Cross-functional collaboration

Project management

Strategic thinking

English communication

Team mentorship

Ausbildung

Graduate degree in life sciences (PhD/MD/PharmD)

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Jobbeschreibung

Humacyte Inc. is seeking a Director of Regulatory Affairs to serve as the FDA liaison for clinical development programs.

This role leads regulatory strategies for early and late-stage products and may co-lead BLA submissions, coordinating with cross-functional teams to ensure timely regulatory deliverables. The position requires a graduate degree in life sciences with 5+ years of regulatory project leadership, strong experience with BLA submissions (CBER preferred), and excellent communication