Food Allergy Education and Research (FARE) is seeking a top-level professional who has a clear understanding of the regulatory process to lead our efforts with federal agencies. This individual will assist and position FARE as the world’s leading food allergy advocacy organization and largest private source of funding of food allergy research.
The Director Regulatory Affairs will be responsible for all regulatory issues and top level regulatory relations for FARE. The Director provides strategic direction and management for key regulatory relations function that is related to one or more of the organization’s regulatory priorities. The position requires a sophisticated understanding of the regulatory (FDA, NIH and CDC) and political processes. The Director of Regulatory Affairs is an expert in his or her key areas of responsibility.
Essential Duties and Responsibilities
- Build relationships with federal agencies, as determined
- Draft comments regarding regulatory issues
- Participate in advocacy strategy and tactics
- Function as subject matter expert on public policy, rules and regulations
- Crafts strategic direction and develops execution plan in consultation with the SVP of External Affairs
- Ability to think strategically and critically evaluate risks to regulatory activities
- Ability to work strategically within a complex, business critical and high-profile development program
- Successful contribution to a major regulatory approval at regional level
- Manage regulatory projects planning, execution, and monitor & control efforts, report on progress, manage project closing as required
- A scientific and clinical understanding of the regulatory sciences
- Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills
- Bachelor’s degree from an accredited college or university or equivalent combination of education, training, and work experience; graduate degree in public policy or related field a plus
- Minimum of 10 years of relevant experience (preferably in a Congressional, agency, or organization setting).