Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory 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 Regulatory 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)
**Applicants must be based in the Milwaukee, Chicago, or Washington, DC metropolitan areas.**
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.
Manager of Regulatory Affairs
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
Requirements
Work Location and Travel
Job Type: Full-time
Benefits:
Schedule:
Work Location: Hybrid remote in Waukesha, WI 53186