Manager, Regulatory Affairs Labeling and Operations

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 also 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:

We are searching for a Manager, Regulatory Affairs Labeling and Operations with a solutions oriented, roll-up-your-sleeves, attitude to join the Regulatory Affairs team, collaborate cross-functionally and externally with vendors. The individual for this position will be responsible for the compilation of labeling documents for all submissions which include labeling information to market Humacyte’s Human Acellular Vessel (HAV) in the US and worldwide. This position will also be accountable for completing tasks in regulatory operations. 

Remote Work Designation: Onsite/Not Remote

  Major Accountabilities:

• This individual will be responsible for working closely with the scientific, regulatory, medical, and commercial/marketing functions to generate, proof-read, and manage versions of labeling documents.
• Liaison with Regulatory, CMC, Marketing, Operations and Sales to manage changing properties to support labeling change projects including launches, promotions and packaging updates.
• Manage advertising and marketing material changes to ensure accuracy and regulatory compliance.
• Prepare and support regulatory submissions for product development, approvals and renewals for FDA and EMA.
• Support regulatory submission of promotional materials. 
• Work closely with external vendors for timely generation, and review of SPL label format for labeling submissions. 
• This position may also support efforts within the company to improve labeling processes e.g., drafting of relevant SOPs, work instructions, generating templates etc. 

Qualifications:

• Requires a Bachelor’s degree, or equivalent on the job experience.
• Six years of Regulatory Affairs work experience is required.
• Minimum of 4 years of direct hand-on experience with global labeling document required, with US focus. Global experience preferred.
• Experience working with Regulatory Operations required. 
• Proficient in working with the Electronic Common Technical Document (eCTD) and regulatory document management systems.

General Competencies:

• Able to communicate effectively in English, both verbally and in writing
• Excellent communication and interpersonal skills
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross-functional team environment
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Ensures Humacyte or other required trainings/certifications are up to date
• Represents the organization in a positive and professional manner

Reports to work on time and as scheduled