Vice President, US Government and Regulatory Affairs

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds leading health and science experts to develop rigorous quality standards for medicines dietary supplements and food ingredients. At USP we believe that scientific excellence is driven by a commitment to fairness integrity and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1300 professionals across twenty global locations working to strengthen the supply of safe high-quality medicines worldwide.
At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunities. Our partnerships standards and research reflect our belief that ensuring broad participation in scientific leadership results in stronger more impactful outcomes for global health.
USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

Brief Job Overview

The Vice President U.S. Government & Regulatory Affairs leads USPs 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 USPs strong foundation this leader will elevate the organizations voice and influence as a private mission-driven institution committed to ensuring a reliable supply of quality medicines.

This role guides USPs proactive approach to shaping regulatory and public policy contributing USPs voice as a critical institutional stakeholder in a range of dialogues relevant to USPs mission. This executive role will advance comprehensive regulatory and legislative intelligence to inform USPs 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 USPs senior ambassadors to top policymakers this leader will advance USPs mission at the highest levels working closely with USPs 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.

How will YOU create impact here at USP

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 USPs 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.

The Vice President US Government and Regulatory Affairs has the following responsibilities:
Provide strategic leadership: and represent USP to senior policymakers and a wide range of stakeholders across government advancing the organizations 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 USPs engagement strategy with the U.S. FDA and Congress strengthen key relationships guide policy positioning and provide timely regulatory and legislative insights to inform USPs 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 USPs 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.

Skills Sought:
Regulatory policy and legislative influence.
Policy shaping while also managing risk.
Coalition building.
Strategic influence.
Agility and innovation in navigating dynamic policy environments in a non-partisan manner.
Leveraging technology platforms to optimize influence.
Exceptional executive level- communications.
Success within a matrixed organization.
Sound judgment and decision quality.

Who is USP Looking For

The successful candidate will have a demonstrated understanding of our mission commitment to excellence through inclusive and equitable behaviors and practices ability to quickly build credibility with stakeholders along with the following competencies and experience:

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.

Additional Desired Preferences

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

Supervisory Responsibilities

This is a supervisory role with direct oversight of senior leaders within the US Government & Regulatory Affairs function. The VP will manage a small team of professionals and provide matrixed leadership across multiple policy regulatory legislative and stakeholder engagement teams.

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.

Compensation
Base Salary Range: USD $236600.00 $319500.00 annually.
Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidates skill set experience qualifications equity and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Required Experience:

Exec