Humacyte Global Inc
Senior Associate, Regulatory CMC
Shannon Plaza, Durham County · Senior
No sponsorshipDetected 3 days ago
RESTComplianceContent MarketingClinical TrialsFDA RegulatoryMedical DevicesResearchAnimal StudiesLeadershipCommunicationCollaborationTime ManagementRegulatory Affairs
About the role
- Prepares CMC regulatory strategies that enable first pass approvals under management supervision.
- Represents RA CMC on product development and life-cycle management teams.
Responsibilities
- HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine.
- The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions.
- This role will directly support strategy, compliance, and submissions for complex manufacturing processes and report to the Head of Product Quality and Regulatory.
- Prepares, reviews, and approves correspondences, submissions, protocols, and reports in support of regulatory filings (IND, IMPD, BLA, MAA, etc.)
- Owner of Regulatory program and system SOPs. As owner ensure alignment with current practices, guidance, and drive continual improvement and periodic review.
- Assure sustainable, harmonized regulatory compliance for Humacyte manufacturing sites and contracted manufacturing operations (as applicable) through expert level insight, evaluation and support
- Identifies and implements regulatory requirements for Design and Development, Technology Transfer, and Manufacturing/Bioprocessing
- Collaborate with Quality on Regulatory communications associated with U.S. and international regulatory inspections, including Pre-Approval Inspections
- Maintain consistent application of ICH Q9 Quality Risk Management principles in product development and lifecycle operations
Requirements
- Demonstrated experience in collaborating with the Quality department to prepare for and execute regulatory inspections including preparation, representation, and closing out of observations
- Demonstrated knowledge of and expertise in product life cycle management, consistent with ICH and other international consensus guidelines
- High degree of flexibility and adaptability.
- They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified.
Nice to have
- Minimum 5 years in the pharmaceutical industry in Regulatory CMC or related function in a Biotechnology-related field.
- Of the 5 years 1-2 years in Regulatory affairs is preferred.
Skills
- Serve as business owner of electronic system used as regulatory documentation repository and submission database
- Self-motivated and critical thinker with outstanding interpersonal and business communication skills.
Compensation
- Competitive base compensation and bonus
Benefits
- Competitive base compensation and bonus
- 401k Plan with 4% Match and no Vesting Schedule
- Medical, Vision and Dental Plans
- Company Paid Long Term/Short Term Disability
- Company Paid Life Insurance
- Assortment of other voluntary benefits, including pet insurance; hospital indemnity; accident & critical illness plans; voluntary life insurance; legal protection plans and more
- 23 Days Paid Time Off (PTO) to start
- Paid Parental Leave Policies
Company info
- Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine.
- Humacyte's initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis, and peripheral arterial disease.
- Preclinical development is also underway in coronary artery bypass graft, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications.
- Humacyte's 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation.
- Humacyte's 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation.
- For more information, visit www.Humacyte.com.
- Durham, NC, Fully Remote
- We are seeking a Senior Associate, Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements.
- Supports products and change control assessments with an understanding of regulations and company policies and procedures under management supervision. Analyzes and approves manufacturing change requests under management supervision.
Visa & Work Authorization
- employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters
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This listing is sourced directly from Humacyte Global Inc's careers page and normalized into a canonical job model.