Senior Associate, Regulatory CMC
Humacyte
August 08, 2026
Remote
United States
Operations
Senior Associate, Regulatory CMC
Responsibilities:
- Prepare, review, and approve regulatory correspondences, submissions, protocols, and reports (IND, IMPD, BLA, MAA, etc.).
- Own the electronic regulatory documentation repository/submission database.
- Own regulatory program and system SOPs; align with current practices/guidance and drive continual improvement.
- Support regulatory CMC strategy development (current and long-term) aligned to company goals; implement plans with Manufacturing and Process Development.
- Identify and mitigate regulatory CMC risks; collaborate with Manufacturing, MSAT, and Process Development.
- Ensure sustainable, harmonized regulatory compliance for manufacturing sites and contracted manufacturing.
- Identify and implement regulatory requirements for Design & Development, Technology Transfer, and Manufacturing/Bioprocessing.
- Partner with Quality on U.S. and international regulatory inspections (including Pre-Approval Inspections).
- Serve as point of contact for CMC compliance/reporting with Development, MSAT, Manufacturing, QA, Validation, and QC.
- Support product and change control assessments; analyze and approve manufacturing change requests.
- Apply ICH Q9 Quality Risk Management principles.
- Manage Tissue Processing regulatory policies/processes per 21 CFR Part 1271 and international HCT/P regulations.
- Apply knowledge of FDA/EU/ROW requirements for aseptic processing, biologics manufacturing, and market authorization.
Qualifications / Required / Preferred:
- 5+ years in pharma Regulatory CMC or related biotech field (1–2 years Regulatory Affairs preferred).
- Experience collaborating with Quality for inspections (prepare, represent, close out observations).
- Record of CMC submission writing/review/approval for biological/cell therapy products (pre-clinical through commercial).
- Experience developing and implementing regulatory/compliance strategies for biologics and medical devices.
- Knowledge of product lifecycle management (ICH and international guidelines).
- Experience planning/executing/closing international inspections (European focus preferred).
- BS in biologics-related discipline (biology, chemistry, biochemistry, microbiology, cell biology, or biotechnology).
Benefits:
- Competitive base compensation and bonus; Stock Options.
- 401k plan with 4% match and no vesting schedule.
- Medical, Vision and Dental Plans; paid disability and life insurance.
- 23 days PTO; 10 company holidays + 2 floating holidays; paid parental leave.
Application instructions:
- Not provided.
Responsibilities:
- Prepare, review, and approve regulatory correspondences, submissions, protocols, and reports (IND, IMPD, BLA, MAA, etc.).
- Own the electronic regulatory documentation repository/submission database.
- Own regulatory program and system SOPs; align with current practices/guidance and drive continual improvement.
- Support regulatory CMC strategy development (current and long-term) aligned to company goals; implement plans with Manufacturing and Process Development.
- Identify and mitigate regulatory CMC risks; collaborate with Manufacturing, MSAT, and Process Development.
- Ensure sustainable, harmonized regulatory compliance for manufacturing sites and contracted manufacturing.
- Identify and implement regulatory requirements for Design & Development, Technology Transfer, and Manufacturing/Bioprocessing.
- Partner with Quality on U.S. and international regulatory inspections (including Pre-Approval Inspections).
- Serve as point of contact for CMC compliance/reporting with Development, MSAT, Manufacturing, QA, Validation, and QC.
- Support product and change control assessments; analyze and approve manufacturing change requests.
- Apply ICH Q9 Quality Risk Management principles.
- Manage Tissue Processing regulatory policies/processes per 21 CFR Part 1271 and international HCT/P regulations.
- Apply knowledge of FDA/EU/ROW requirements for aseptic processing, biologics manufacturing, and market authorization.
Qualifications / Required / Preferred:
- 5+ years in pharma Regulatory CMC or related biotech field (1–2 years Regulatory Affairs preferred).
- Experience collaborating with Quality for inspections (prepare, represent, close out observations).
- Record of CMC submission writing/review/approval for biological/cell therapy products (pre-clinical through commercial).
- Experience developing and implementing regulatory/compliance strategies for biologics and medical devices.
- Knowledge of product lifecycle management (ICH and international guidelines).
- Experience planning/executing/closing international inspections (European focus preferred).
- BS in biologics-related discipline (biology, chemistry, biochemistry, microbiology, cell biology, or biotechnology).
Benefits:
- Competitive base compensation and bonus; Stock Options.
- 401k plan with 4% match and no vesting schedule.
- Medical, Vision and Dental Plans; paid disability and life insurance.
- 23 days PTO; 10 company holidays + 2 floating holidays; paid parental leave.
Application instructions:
- Not provided.