Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
This position will report directly to Chief Regulatory Officer. This position will function as Chair of the Medical, Legal and Regulatory Committee (MLR), and lead the effort of establishing the company’s promotional review system and process collaborating with Medical and Legal in preparation for commercial launch readiness. This position will ensure that strategic regulatory subject matter expertise is provided on advertising and promotional materials/activities for assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and company policy.
This position will also function as the primary regulatory representative to support activities with commercial and medical affairs.
Major Accountabilities:
This person is accountable to review and support all promotional, non-promotional and public materials, ensuring materials are fair, balanced, on-label, and meet function-specific standards while achieving marketing’s objectives.
Special Competencies:
General Competencies:
Qualifications:
Perks:
Stock Options
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
23 Days Paid Time Off (PTO)
10 Company Designated Holidays + 2 Floating Holidays
Paid Parental Leave Policies
**Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruiters.**