Manager of Regulatory Affairs

About the American Society of Gene & Cell Therapy

The American Society of Gene & Cell Therapy (ASGCT) is the primary professional organization for gene and cell therapy, with a broad membership base including scientists, clinical researchers, physicians, patient advocates, and pharmaceutical, biotechnology, and other professionals. The mission of the Society is to advance knowledge, awareness, and education leading to the discovery and clinical application of genetic and cellular therapies to alleviate human disease.

Summary

Reporting to the Director of Policy & Advocacy, the Manager of Regulatory Affairs plans, executes, and oversees daily activities associated with ASGCT’s regulatory priorities. Primary responsibilities include reviewing, analyzing, and responding to relevant Food & Drug Administration (FDA) regulations with an emphasis on regenerative medicine. The position is hybrid and will require up to 20% of domestic travel for related regulatory work.

Responsibilities

• Manage systems and processes for analyzing, reporting, and responding to FDA regulations related to cell, gene, and RNA therapies.
• Provide guidance to, and collaborate with, relevant subject matter experts to ensure timely execution of regulatory projects.
• Manage the Society’s Annual FDA Liaison Meeting and other potential meetings with regulatory officials.
• Collaborate with ASGCT policy and advocacy staff in the development of regulatory programming content (i.e., Policy Summit, Annual Meeting).
• Serve as a staff liaison to ASGCT’s Regulatory Affairs Committee and CMC Committee.
• Remain current, and communicate frequently with ASGCT staff and members, providing timely updates on industry trends within areas of responsibility.
• Other duties as assigned.

Requirements

• Excellent verbal and written communication skills.
• Attention to detail.
• Strong management, interpersonal, organizational, and team building skills.
• Highly motivated with proven project management skills, and the ability to prioritize deadlines.
• Bachelor’s Degree required.
• Five or more years of combined regulatory, policy, and/or advocacy experience. Prior experience working in or with member societies and/or industry trade associations preferred.

Work Location and Travel

• ASGCT is headquartered in suburban Milwaukee with a satellite office in Washington, DC.
• Applicants must be based in the Milwaukee, Chicago, or Washington, DC metropolitan areas.
• Chicago and Washington, DC metropolitan employees are expected to travel to the executive office in Milwaukee several times per year.
• Employees enjoy a flexible hybrid work schedule.

Call (414) 278-1341 for more information on how to apply.