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.
Biologics, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
The Vice President, US Regulatory Engagement and Government Affairs is USP’s senior regulatory professional who builds and leads USP’s regulatory engagement strategy, represents the organization to senior regulatory agency and US federal and state officials, provides counsel to USP’s program units and expert committee staff, drives the establishment of USP’s regulatory policy positions, ensures timely identification of regulatory developments and key trends, and leads the USP Regulatory and Government Affairs teams. This leader will be relied upon to help shape the organization’s overall strategies and to effectively respond to regulatory and policy developments. She/he will partner with other USP senior leaders to build and implement a comprehensive approach to working with policy makers, stakeholders and manufacturers of medicines and supplements to help ensure the quality of medicines in the United States, and will be integrated into senior leadership committees as a member of the USP Global Leadership Team and the Global External Affairs Leadership Team.
Roles and Responsibilities
The senior leader in this role leads and inspires a talented team of regulatory and government affairs professionals and is responsible for the following:
Regulatory Agency Engagement and Collaboration Strategy . Lead, develop, and implement a strategy to collaborate with US regulatory agencies including US FDA, CMS and HHS to advance the efficient development of quality standards and to leverage USP capabilities to advance public health and patient safety priorities.
Key Relationship Management . Maintain and build organizational relationships with regulatory, and policy influencers and decision makers in government and industry
Regulatory Intelligence. Maintain robust regulatory intelligence initiatives to track external developments and trends, communicating and interpreting them across the USP organization .
Regulatory Policy and Advocacy. Lead the development and establishment of cohesive and consistent organizational positions on regulatory policy developments and form regulatory policy proposals consistent with USP’s mission. Develop and implement advocacy initiatives with partner organizations to advance regulatory policy priorities.
Industry Regulatory Engagement. Build a program to engage with regulatory affairs professionals working in industry to gain insights, establish dialogue and seek opporutnities to collaborate on shared objectives.
Regulatory Business Partner to USP Program Units and Scientific Liaisons Committees. Partner with USP’s program units and scientific liaison staff to help consider, align and/or respond to regulatory developments in the course of standard setting and training and education initiatives for industry, and healthcare practitioners.
Oversight of US Government Affairs. Provide high-level leadership to USP’s US Government Affairs group and Washington office and ensure alignment of engagement activities at the US Congressional and state policy levels with regulatory engagements.
BA/BS in a relevant science discipline, public health, public policy or other relevant field.
Minimum of twelve (12) years of leadership experience in regulatory policy working in the US FDA, relevant trade association, or in the Pharmaceutical/Biopharmaceutical industry
Seven (7) years or more of robust and successful engagement with the US FDA and/or coalitions of stakeholders on regulatory policy topics.
Minimum of five (5) years of supervisory experience
Demonstrable and strong written and verbal communication skills.
Preferred Skills and Qualifications
5+ years of leadership experience in the pharma/biopharma industry strongly preferred
Advanced degree preferred in law, medicine, pharmacy or other relevant field.
Deep understanding of the US Food & Drug Administration’s structures and processes.
Knowledge of medicine quality regulatory topics and high-level understanding of basic medicine manufacturing.
Experience in biologics and areas of medical innovation.
Proven ability to work effectively and collaboratively in a matrixed organization. Success in leading and inspiring multi-disciplinary teams.
Proven aptitude for building relationships, credibility, and trust with stakeholders.
Strong critical thinking and problem-solving skills.
Flexibility to react to and constructively manage rapidly changing policy and political environments
Internal Number: ID:1626-679
About The U.S. Pharmacopeial Convention (USP)
The U.S. Pharmacopeial Convention (USP) is a global nonprofit organization focused on improving global public health through public quality standards; programs to enhance the capabilities of stakeholders to produce quality medicines, supplements and foods; and advocacy to drive awareness, investment and action. USP is powered by the work of over 1000 scientific experts who volunteer on USP standard-setting committees, 470 organizations in the USP Convention, and 1300 staff working in eight offices around the world.
USP offers an impressive benefits package, including:
•Generous paid time off – 13 paid holidays, 10 sick days and 15 vacation days per year to start
•An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
•Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)
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.