Senior Associate, Regulatory CMC
Humacyte
August 31, 2026
Remote
United States
Operations
Senior Associate, Regulatory CMC
Responsibilities:
- Prepare/review/approve regulatory correspondences, submissions, protocols, and reports (IND, IMPD, BLA, MAA, etc.).
- Serve as business owner of the regulatory documentation repository and submission database.
- Own Regulatory program and system SOPs; ensure alignment with current guidance and drive continual improvement.
- Develop and implement current/long-term regulatory CMC strategies aligned with company goals.
- Identify and mitigate regulatory CMC risks; collaborate with Manufacturing, MSAT, and Process Development.
- Ensure sustainable, harmonized regulatory compliance for manufacturing sites and contracted operations.
- Identify/implement regulatory requirements for Design & Development, Technology Transfer, and Manufacturing/Bioprocessing.
- Partner with Quality on U.S./international inspection communications (including pre-approval inspections).
- Act as point of contact for CMC compliance/reporting with Development, MSAT, Manufacturing, QA, Validation, and QC.
- Support and approve product/change control assessments for manufacturing changes.
- Apply ICH Q9 Quality Risk Management principles.
- Manage Tissue Processing regulatory policies/procedures per 21 CFR Part 1271 and international HCT/P regulations.
- Demonstrate expertise in FDA/EU/ROW regulations for aseptic processing, biologics manufacturing, and human cell/tissue-based products.
Qualifications:
- 5+ years in pharmaceutical industry Regulatory CMC (biotechnology-related); 1–2 years in Regulatory Affairs preferred.
- Experience collaborating with Quality for regulatory inspections (prep/representation/closeout).
- Proven CMC submission writing/review/approval for biological and cell therapy processes.
- Experience developing regulatory/compliance strategies for biologics and medical devices.
- Knowledge of product lifecycle management (ICH/international guidelines).
- Experience with international inspections; European submissions focus.
- Strong collaboration, organization, adaptability, communication.
Education:
- BS in biologics-related discipline (biology/chemistry/biochemistry/microbiology/cell biology/biotechnology).
Benefits highlights:
- Competitive base + bonus; Stock Options; 401k (4% match); Medical/Vision/Dental; paid disability and life insurance; 23 days PTO; holidays and paid parental leave.
Application instruction (per posting):
- No U.S. employment sponsorship; no unsolicited resumes from 3rd-party firms/agency recruiters.
Responsibilities:
- Prepare/review/approve regulatory correspondences, submissions, protocols, and reports (IND, IMPD, BLA, MAA, etc.).
- Serve as business owner of the regulatory documentation repository and submission database.
- Own Regulatory program and system SOPs; ensure alignment with current guidance and drive continual improvement.
- Develop and implement current/long-term regulatory CMC strategies aligned with company goals.
- Identify and mitigate regulatory CMC risks; collaborate with Manufacturing, MSAT, and Process Development.
- Ensure sustainable, harmonized regulatory compliance for manufacturing sites and contracted operations.
- Identify/implement regulatory requirements for Design & Development, Technology Transfer, and Manufacturing/Bioprocessing.
- Partner with Quality on U.S./international inspection communications (including pre-approval inspections).
- Act as point of contact for CMC compliance/reporting with Development, MSAT, Manufacturing, QA, Validation, and QC.
- Support and approve product/change control assessments for manufacturing changes.
- Apply ICH Q9 Quality Risk Management principles.
- Manage Tissue Processing regulatory policies/procedures per 21 CFR Part 1271 and international HCT/P regulations.
- Demonstrate expertise in FDA/EU/ROW regulations for aseptic processing, biologics manufacturing, and human cell/tissue-based products.
Qualifications:
- 5+ years in pharmaceutical industry Regulatory CMC (biotechnology-related); 1–2 years in Regulatory Affairs preferred.
- Experience collaborating with Quality for regulatory inspections (prep/representation/closeout).
- Proven CMC submission writing/review/approval for biological and cell therapy processes.
- Experience developing regulatory/compliance strategies for biologics and medical devices.
- Knowledge of product lifecycle management (ICH/international guidelines).
- Experience with international inspections; European submissions focus.
- Strong collaboration, organization, adaptability, communication.
Education:
- BS in biologics-related discipline (biology/chemistry/biochemistry/microbiology/cell biology/biotechnology).
Benefits highlights:
- Competitive base + bonus; Stock Options; 401k (4% match); Medical/Vision/Dental; paid disability and life insurance; 23 days PTO; holidays and paid parental leave.
Application instruction (per posting):
- No U.S. employment sponsorship; no unsolicited resumes from 3rd-party firms/agency recruiters.