The U.S. Pharmacopeial Convention (USP) Senior Director, US Regulatory Policy in Rockville, Maryland
Who is USP?
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
The Senior Director will be responsible for:
building a regulatory policy portfolio related to the quality of medicines and innovative therapies, and a more resilient global supply chain for medical products.
defining and advancing USP’s positions on U.S. regulatory policy issues and building an advocacy strategy to influence the regulatory policy environment.
representing USP in policy related external dialogues, to expand awareness and understanding of the value of USP's standards in advancing medicine quality and market access.
bringing insights from these dialogues to internal partners to help inform USP’s work.
How will YOU create impact here at USP?
By working across the USP organization to engage, leverage, and optimize USP’s scientific and policy expertise to build a regulatory policy portfolio that is reflective of USP’s mission and informed by scientific and regulatory trends. Key areas of work will focus on the quality of small and large molecule medicines, dietary supplements, and a more resilient global supply chain for medical products.
The objectives of this role are:
1). To analyze and assess relevant regulatory policy information and trends that may have an impact on USP programs,
2). To work with internal Subject Matter Experts to create and shape positions on relevant regulatory policy topics, and
3). To contribute USP’s perspective and scientific expertise to policy shaping dialogues.
The successful candidate will be joining a diverse team that is focused on stakeholder engagement, evidence development, communications, and policy and will work closely with and cultivate collaboration among team members and across divisions, especially with USP’s Regulatory Affairs and Public Policy team members. This position reports to the Vice President, US Government & Regulatory Affairs, and coordinates closely with colleagues across USP Global External Affairs and our USP organization.
Establish regulatory policy positions:
• Develop and own the execution of an evidence-based, stakeholder-informed, regulatory policy agenda, including building regulatory policy positions, consistent with USP’s mission and aligned to USP priorities.
• Support regulatory commenting efforts for assigned priorities, including facilitating the input of USP subject matter experts.
• Analyze and assess impact of meaningful emerging regulatory policies and trends on USP projects and standard setting activities.
• Champion strong partnerships with internal team members to ensure aligned objectives and to find opportunities for advocacy engagement.
• Coordinate with Government Affairs and Regulatory Intelligence to understand and anticipate evolving regulatory and public policy trends and work with internal team members to respond appropriately.
Engage externally to shape policy discussions:
• Lead, develop, and implement an engagement plan with the broader regulatory affairs community in industry and the association sector to enhance dialogue on identified regulatory policy priorities.
• Engage and develop relationships with opinion leaders and subject matter experts, professional groups and associations, and other related stakeholders to gain insights that may shape USP’s work while also contributing to policy shaping dialogues.
• Represent USP externally at key industry and association conferences where the scientific and regulatory affairs communities convene on priority policy topics to expand awareness and understanding of the value of USP standards and to appropriately shape and influence the regulatory policy environment.
• Build upon existing relationships and maintain strong collaborations with external professional groups, think-tanks, academic groups, and policy organizations.
Who USP is Looking For?
The successful candidate will have a proven understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with team members, along with the following competencies and experience:
• Advanced degree in relevant policy, public health, regulatory, legal, or related field with 11-13 years of regulatory/policy/advocacy equivalent experience.
• Substantial experience engaging with biopharmaceutical industry professional associations, regulatory affairs, and policy professionals on shaping regulatory policy issues.
• Established external network in subject matter area of focus.
• Recognized experience in leading/implementing regulatory policy campaigns.
• Solid understanding of the U.S. regulatory environment, the Federal Food, Drug and Cosmetic Act, and associated regulations and mentorship documents
• Shown success at regulatory, industry, and partner engagement with ability to lead highly sophisticated situations and engender trust when taking care of critical issues.
• Experience working in a matrixed environment.
• Positive relationship management and outstanding communication skills.
• Ability to influence without authority, demonstrate resourcefulness, and operate independently.
Additional Desired Preferences
Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifiers for candidate consideration.
• 13-15 years of Regulatory Policy or Regulatory Affairs experience with at least five years of proven track record in the biopharmaceutical industry, a relevant association, or FDA.
• Advanced degree in regulatory science and/or policy, political science, public policy, public health, law, medicine, or another related field.
• Yes, one: Senior Regulatory Policy Manager
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired:
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
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
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Ext. Affairs, Regulatory, & Communications
Job Type Full-Time