Senior Director, External Affairs

Company: United States Pharmacopeia
Location: Rockville
Posted on: June 26, 2025

Job Description:

Description 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 1,300 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 Senior Director, External Affairs Biologics will lead USPs efforts to shape regulatory policy and engage with and influence key stakeholders to advance USP standards for biologics products. This role will partner closely with the Biologics Division and colleagues in GEA and RPS and serve as the lead in a coordinated and comprehensive regulator/policy maker/stakeholder group strategy to advance USPs current and future portfolio of solutions to advance development and supply of biologics medicines. Shaping the regulatory environment in the US with direct and indirect engagement with the US FDA, along with building stakeholder support will be central to the role. Moreover, while the US is primary, advancing USP goals in biologics in other regions will also be a priority. In the course of engaging with policy makers, influencers, and stakeholders, the Senior Director will also gather, synthesize, and communicate insights among USP leaders which can be integrated into broader planning. 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 Senior Director, External Affairs Biologics has the following responsibilities: Comprehensive Biologics Engagement and Influence Plan: Lead the development of a comprehensive external affairs engagement and influence plan to advance the development and utilization of USPs current and future biologics standards portfolio, working across Global External Affairs in close collaboration with the Biologics Division. Stakeholder Management: Collaborate with colleagues in Global External Affairs and the Biologics Divisions identify, map, and nurture relationships with leading influencers and decision makers on supply chain resilience topics relevant to USPs supply chain portfolio. This will include prioritized and deeper engagement with identified organizations. Thought Leadership: Partner with colleagues in Biologics and Global Communications to develop and ensure execution of a thought leadership program that engages influencers in dialogue about the challenges and USP solutions to expanding the supply of biologics medicines. Focus areas will including standards and related regulatory matters in the US, and opportunities in advanced biologics medicines. Excellent written and other communications that clearly communicates the contributions of USP standards to addressing key problems faced by regulators and industry will be essential. Regulator Engagement and Influence : Build and ensure execution of an engagement plan for the US FDA and selected international regulators to advance utilization of USP biologics standards and engagement in standards development. Representation: In collaboration with colleagues, represent USP at selected external dialogues as appropriate. 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: Bachelors degree in Health Policy, Political Science, Biology, Pharmaceutical Sciences, or a relevant field. Minimum of 13-15 years of combined experience in policy roles, regulatory affairs, or related fields, with 12 years at a senior level. Proven track record of developing and implementing comprehensive influencing strategies. Proven ability to synthesize complex policy frameworks and drive action. Experience engaging with U.S. and international regulators, policymakers, industry leaders, and stakeholder groups on biologics topics. Strong public speaking and writing skills, with experience representing organizations in high-stakes settings. Demonstrated experience working with senior policy makers in a bi-partisan manner. Additional Desired Preferences Advanced degree (Masters or Ph.D.) in a relevant field. Combination of commercial pharmaceutical industry and government/regulatory experience. Familiarity with global regulatory frameworks affecting pharmaceutical supply chains. Supervisory Responsibilities Yes 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 $203,000- 263,500 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. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor. Job Category Ext. Affairs, Regulatory, & Communications Job Type Full-Time

Keywords: United States Pharmacopeia, Frederick , Senior Director, External Affairs, Science, Research & Development , Rockville, Maryland