Sr. Director, Regulatory Promotional Review

Job Description

Job Description

DEPARTMENT : Regulatory Affairs

LOCATION : Durham, NC, Partially Remote

COMPANY : 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. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. 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.

JOB SUMMARY :

This position will report directly to the Chief Regulatory Officer. This position will function as Chair of the Medical, Legal and Regulatory Committee (MLR), and lead the company’s promotional review system and process collaborating with other senior leaders of the organization, 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.

ESSENTIAL FUNCTIONS :

This person is accountable to review and support all promotional, non-promotional and public materials, ensuring materials are fair, balanced, and on-label, and meet function-specific standards while achieving marketing’s objectives.

• Ensure compliance with FDA laws and regulations, and company policies.
• Ensure accuracy with approved label.
• Ensure materials are fairly balanced, tie to language in ISI and PI.
• Submit promotional material to FDA according to regulation.

EXPERIENCE & QUALIFICATIONS :

COMPENSATION & BENEFITS HIGHLIGHTS :

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and / or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.