The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
This strategic leader in this role will lead the development of USP regulatory and public policy positions and be responsible for the creation of evidence-based policy content to help advance the supply of quality medicines and biomedical innovations. This role requires development of robust, substantive policy materials, including, but not limited to, white papers, research collaborations, journal articles, public policy position statements, and formal comments to government agencies. In some cases, these will be developed with staff resources but sometimes through collaborations with academic institutions and consultants. This role includes leadership of a team of professionals focused on US regulatory and public policy and requires collaboration across the USP organization to develop USP policy positions and to leverage the expertise of USP staff and volunteers. In addition, this leader will work with colleagues working internationally and the USP Quality Institute to shepherd a policy agenda that complements USP’s 2020-2025 strategic plan.
Roles and Responsibilities
Develop USP public policy program strategy – create a five year plan to build public policy content upon which to expand USP’s contributions to policy dialogue to improve the supply of quality medicines.
Execute on policy content development goals
Leverage and collaborate with USP’s science and public health resources, including staff and USP’s volunteer bodies, to build substantive policy content (policy positions, white papers, formal comment letters, etc.) to convey USP’s perspective on timely topics.
Lead the development of platforms and content to leverage content to inform regulatory and public policy dialogues.
Director, Regulatory Policy
Senior Manager, Innovation Policy
Senior Manager, US Public Policy
Bachelor’s degree in relevant field.
15 years of professional experience working in life sciences or public health including more than five years managing complex projects or programs. Experience working with academic and consulting partners preferred.
3 years of experience managing people.
Demonstrable experience in writing and managing the development of substantive policy materials in a variety of forms and for different audiences (e.g., public policy makers, regulatory leaders, stakeholder organizations, etc).
Significant, successful and demonstrable relevant career experience leading and working with teams in a science-focused matrixed global organization
Experience in leading health policy, public health, and/or health economics research
Impeccable written and verbal communications skills
Results driven with demonstrated successful outcomes.
Ability to handle multiple priorities in a fast-paced environment, responding to current events but also laying the foundation for future advocacy efforts.
Advanced degree in public policy, public health, law, medicine, or other related field
Experience working in a policy institute (non-profit, government or corporate) or in an academic policy development role
Experience working internationally
Experience working with academic research partners
For over 200 years, USP has worked to build trust where it matters most: in the world's medicines, dietary supplements and foods. Through our rigorous science and the public quality standards we set, USP helps protect patient safety and improve the health of people around the world.
USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected.