Senior Director, CMC Regulatory Affairs
Humacyte
June 25, 2026
Remote
United States
Corporate Functions
JOB SUMMARY:
Senior Director, Head of Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. Leads regulatory strategy, compliance, and submissions for complex manufacturing processes; reports to the Chief Regulatory Officer.
ESSENTIAL FUNCTIONS:
- Generate, review, and approve CMC regulatory submissions.
- Lead and manage the RA CMC team; mentor team members.
- Develop short- and long-term regulatory CMC strategies aligned to company goals; implement with Manufacturing and Process Development.
- Identify regulatory CMC risks; recommend mitigations; collaborate with senior leaders across Manufacturing, MSAT, and Process Development.
- Ensure sustainable, harmonized regulatory compliance for manufacturing sites and contracted operations.
- Define regulatory requirements for Design & Development, Technology Transfer, and Manufacturing/Bioprocessing.
- Collaborate with Quality on U.S./international inspection communications (including Pre-Approval Inspections).
- Act as main CMC compliance/reporting contact across Development, MSAT, Manufacturing, QA, Validation, and QC.
- Represent the company in CMC discussions with regulators (e.g., FDA and other competent authorities).
- Prepare/review/approve regulatory correspondences, submissions, protocols, and reports (IND, IMPD, BLA, MAA, etc.).
- Apply ICH Q9 Quality Risk Management principles.
- Maintain tissue processing policies/processes per 21 CFR Part 1271 and relevant international HCT/P regulations.
- Apply knowledge of U.S., EU, and ROW regulations (including 21 CFR Parts 11, 210, 211, 600, 820, 1271; EudraLex Vol 4; 2001/83/EC, 2004/23/EC).
EXPERIENCE & QUALIFICATIONS:
- 8+ years in director-level+ Regulatory CMC (or related) in biotechnology.
- Experience partnering with Quality for inspections (prep, representation, closeout).
- Proven record writing/reviewing/approving biological & cell therapy CMC submissions across preclinical/clinical/commercial.
- Experience developing and implementing regulatory/compliance strategies for biologics and medical devices.
- Expertise in product lifecycle management (ICH/international guidelines).
- Experience planning/executing/closing international inspections, with a focus on Europe.
EDUCATION:
- BS in a biologics-related discipline (biology, chemistry, biochemistry, microbiology, cell biology, or biotechnology).
BENEFITS:
- Competitive base compensation and bonus; stock options.
- 401k Plan with 4% match (no vesting schedule).
- Medical, Vision, Dental; paid disability and life insurance.
- 23 days PTO to start; 10 company holidays + 2 floating; paid parental leave.
APPLICATION INSTRUCTIONS:
- No U.S. employment sponsorship; no acceptance of unsolicited resumes from 3rd-party firms/agency recruiters.
Senior Director, Head of Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. Leads regulatory strategy, compliance, and submissions for complex manufacturing processes; reports to the Chief Regulatory Officer.
ESSENTIAL FUNCTIONS:
- Generate, review, and approve CMC regulatory submissions.
- Lead and manage the RA CMC team; mentor team members.
- Develop short- and long-term regulatory CMC strategies aligned to company goals; implement with Manufacturing and Process Development.
- Identify regulatory CMC risks; recommend mitigations; collaborate with senior leaders across Manufacturing, MSAT, and Process Development.
- Ensure sustainable, harmonized regulatory compliance for manufacturing sites and contracted operations.
- Define regulatory requirements for Design & Development, Technology Transfer, and Manufacturing/Bioprocessing.
- Collaborate with Quality on U.S./international inspection communications (including Pre-Approval Inspections).
- Act as main CMC compliance/reporting contact across Development, MSAT, Manufacturing, QA, Validation, and QC.
- Represent the company in CMC discussions with regulators (e.g., FDA and other competent authorities).
- Prepare/review/approve regulatory correspondences, submissions, protocols, and reports (IND, IMPD, BLA, MAA, etc.).
- Apply ICH Q9 Quality Risk Management principles.
- Maintain tissue processing policies/processes per 21 CFR Part 1271 and relevant international HCT/P regulations.
- Apply knowledge of U.S., EU, and ROW regulations (including 21 CFR Parts 11, 210, 211, 600, 820, 1271; EudraLex Vol 4; 2001/83/EC, 2004/23/EC).
EXPERIENCE & QUALIFICATIONS:
- 8+ years in director-level+ Regulatory CMC (or related) in biotechnology.
- Experience partnering with Quality for inspections (prep, representation, closeout).
- Proven record writing/reviewing/approving biological & cell therapy CMC submissions across preclinical/clinical/commercial.
- Experience developing and implementing regulatory/compliance strategies for biologics and medical devices.
- Expertise in product lifecycle management (ICH/international guidelines).
- Experience planning/executing/closing international inspections, with a focus on Europe.
EDUCATION:
- BS in a biologics-related discipline (biology, chemistry, biochemistry, microbiology, cell biology, or biotechnology).
BENEFITS:
- Competitive base compensation and bonus; stock options.
- 401k Plan with 4% match (no vesting schedule).
- Medical, Vision, Dental; paid disability and life insurance.
- 23 days PTO to start; 10 company holidays + 2 floating; paid parental leave.
APPLICATION INSTRUCTIONS:
- No U.S. employment sponsorship; no acceptance of unsolicited resumes from 3rd-party firms/agency recruiters.