Government Affairs Manager implements strategic plans and oversees engagement objectives to develop and maintain productive relations with all levels of government authorities that will support and enhance the businesses' goals. Manages teams that build relationships and liaise with government entities(federal, state, provincial, or local) that regulate or influence business activities. Being a Government Affairs Manager performs ongoing monitoring and analysis of proposed legislation, emerging issues, and trends to determine the potential impact on the organization. Collaborates with industry groups and organizations with complementary objectives to achieve objectives. Additionally, Government Affairs Manager creates communication vehicles and delivers messaging to inform and support business leaders. Requires a bachelor's degree in public policy, public administration, business or equivalent. Typically reports to a director. The Government Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Government Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Manager, Regulatory Affairs Labeling
Position Profile
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 demonstrate 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 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 must also be willing to assist the team for completing tasks in regulatory operations when needed.
Remote Work Designation: Partially Remote
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**Please note, Humacyte does not provide sponsorship at this time and does not accept unsolicited resumes from recruiters.**
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