Manager, Regulatory Affairs

This role is responsible for the management of the Society’s federal regulatory policy with an emphasis on the Food & Drug Administration (FDA).


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Under the leadership of the Director of Policy & Advocacy, the Manager of Regulatory Affairs is responsible for the management of the Society’s federal regulatory policy with an emphasis on the Food & Drug Administration (FDA). The position will be remote with up to 20% of domestic travel for related regulatory work, ASGCT Annual Meeting, etc.

Responsibilities

  • Manage the strategic analysis and review of regulation through the rulemaking process, FDA guidances, and related organization advocacy efforts, which include drafting official ASGCT responses and coordinating multi-stakeholder responses.
  • Manage and support the Society’s relationships with official liaisons of governmental agencies to foster a two-way communication and grow the awareness of the Society’s regulatory policy positions.
  • Work in concert with ASGCT policy and advocacy staff to develop content for regulatory programming (i.e., Policy Summit, Annual Meeting, and OTAT workshops)
  • Engage with FDA and its advisory committees via the Annual Liaison Meeting.
  • Work collaboratively to draft regulatory policy comments to other governmental bodies as needed.
  • Manage and support the Society’s regulatory advocacy efforts, serving as a staff liaison to ASGCT’s Regulatory Affairs Committee and CMC Committee.
  • As needed, represent ASGCT and engage ASGCT members in non-governmental quasi-regulatory organizations on standards-related input (e.g., International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the Standards Coordinating Body for Regenerative Medicine, National Institute of Standards and Technology, United States Pharmacopeia).
  • Communicate and provide summaries and talking points for Society leaders and other stakeholders on regulatory matters.
  • Stay updated on new technologies, best practices, and industry trends within areas of responsibility.
  • Other duties as assigned.

Requirements

  • Outstanding interpersonal, organizational, and communications skills. Highly motivated with the ability to manage multiple projects and prioritize deadlines. Able to work successfully in a team environment.
  • Bachelor’s Degree required. Advanced degree in biological science, public policy, political science, or a related area is preferred.
  • Five or more years of relevant regulatory policy or advocacy experience, ideally within a combination of settings such as professional and trade associations, pharmaceutical or biotechnology industry, and public service.

ASGCT is a 501(c)3 nonprofit organization and an equal opportunity employer. For more information, please visit www.asgct.org.

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Employee assistance program
  • Flexible schedule
  • Health insurance
  • Life insurance
  • Paid time off
  • Parental leave
  • Professional development assistance
  • Tuition reimbursement
  • Vision insurance

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2022

ASGCT Policy Summit

September 26-27, 2022

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