Vice President, US Government and Regulatory Affairs

USP • Rockville, MD

32d

About The Position

The Vice President, U.S. Government & Regulatory Affairs, leads USP’s strategy and engagement with federal agencies with emphasis on U.S. FDA engagement, Congress, and occasionally state governments and leads the development of U.S. public policy. Building on USP’s strong foundation, this leader will elevate the organization’s voice and influence as a private, mission-driven institution committed to ensuring a reliable supply of quality medicines. This role guides USP’s proactive approach to shaping regulatory and public policy, contributing USP’s voice as a critical institutional stakeholder in a range of dialogues relevant to USP’s mission. This executive role will advance comprehensive regulatory and legislative intelligence to inform USP’s work, ensure early risk identification, and manage critical relationships, enabling the organization to navigate a rapidly evolving policy landscape with agility and nonpartisan integrity. Importantly, the VP will ensure senior-level dialogue with FDA leadership on relevant regulatory topics and contribute to effective collaboration with the Agency on standard-setting. As one of USP’s senior ambassadors to top policymakers, this leader will advance USP’s mission at the highest levels working closely with USP’s senior staff to shape strategy, manage risk, and align enterprise-wide priorities. This role supervises a team of experienced professionals and plays a key leadership role across the organization. As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

Requirements

• BA/BS in public policy, regulatory policy, political science, communications, or a related field.
• Thirteen (13) years of combined experience working on healthcare issues in the life sciences sector and/or in a relevant regulatory agency or legislative function.
• Experience working in a relevant capacity with the U.S. FDA.
• Experience working directly on relevant advocacy topics at the Congressional level.
• Significant people management experience.
• Demonstrated experience working in one or more key topical areas relevant to USP including biologics, generic medicines, and medicine supply chain resilience/drug shortages.
• Experience operating effectively in dynamic regulatory and legislative environments.
• Demonstrated success working in a matrixed organization.
• Experience representing an influential organization in public forums.

Nice To Haves

• Advanced degree strongly preferred (e.g., law, public policy, public health, or related discipline).

Responsibilities

• Provide strategic leadership: and represent USP to senior policymakers and a wide range of stakeholders across government, advancing the organization’s mission and priorities across federal agencies, Congress, and state governments. This executive also engages with leaders across the USP organization to help shape organizational strategy and risk mitigation.
• FDA & Congressional Engagement: Lead USP’s engagement strategy with the U.S. FDA and Congress, strengthen key relationships, guide policy positioning, and provide timely regulatory and legislative insights to inform USP’s enterprise and impact strategy.
• Public Policy Content Development: Oversee the development of high quality, evidence-based policy content that informs regulatory and legislative decision-making.
• U.S. Government Collaboration: Expand and strengthen USP’s partnerships with federal agencies, positioning USP as a trusted, science-driven collaborator.
• Strategic Influence: Shape enterprise strategy through analysis of emerging policy trends, risks, and opportunities to ensure USP remains proactive, credible, and mission driven in a dynamic policy environment.

Benefits

• USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive