Senior International Regulatory Affairs Manager

The U.S. Pharmacopeial Convention (USP); Rockville (MD); Sur place; USD 126 000 - 172 000; Plein temps

Résumé du poste

USP in Rockville is seeking a Senior International Regulatory Affairs Manager to lead regulatory content development and global regulator engagement. You will collaborate with USP teams worldwide to translate complex standards into practical policy resources and support authorities across regions.

The role requires strong communication, policy experience, and the ability to drive cross-functional initiatives within a global health standards organization.

Qualifications

• Bachelor’s degree in life sciences, public policy, or related field.
• Eight years of regulatory intelligence/affairs with international teams.
• Experience in a science-based organization related to public health or life sciences.
• Knowledge of regulatory policy making processes and policy writing.
• Experience translating scientific or regulatory information into clear policy content.
• Excellent communication, presentation, and cross-cultural collaboration skills.
• Strong analytical and writing skills; ability to synthesize complex information.
• Project management and organizational abilities to adapt to change.

Responsabilités

• Lead development of evidence-based regulatory content across regions with cross-functional USP teams.
• Support deployment of content and gather feedback to guide updates and priorities.
• Lead planning and management of a global Regulators Forum to engage authorities.
• Provide targeted country-level regulatory support as assigned.

Connaissances

Excellent communication

Strong analytical and writing skills

Project management

Cross-cultural communication

Formation

Bachelor’s degree

Description du poste

Description

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's 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 minds-regardless of background to 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 International Regulatory Affairs Manager serves as a critical enabler of regulatory engagement and influence to support the realization of USP's mission priorities in regions across the globe. The Senior Manager will lead the development of a portfolio of evidence-based regulatory content that could include analyses, toolkits and other materials to support engagement with regulators aligned with enterprise priorities. The role collaborates across USP functions and regions to translate scientific and regulatory information into practical policy resources that strengthen engagement with regulatory authorities worldwide and supports the understanding and application of USP standards and programs. This role will also develop and lead a platform to connect and engage regulators across the regions on topics relevant to USP's mission. The role reports to the VP, International Government & Regulatory Affairs (IGRA) and is a key role within the broader Global External Affairs function.

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, 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.

Senior International Regulatory Affairs Manager has the following responsibilities:

• Lead the development of a portfolio of evidence-based regulatory content that could include analyses, toolkits and other materials that support enterprise priorities and that can be deployed to and tailored in regions. The Sr. Manager will engage with global commercial teams and Global External Affairs colleagues to assess opportunities and needs to inform the focus of the content and then lead its development in collaboration with cross-functional USP teams. Potential topical areas include API quality; standards for biologics; new biologic / peptide treatments; appropriate use of quality standards; integration of digital tools into quality assurance.
• Support the deployment of the developed content across regions and stakeholder groups, including developing a process by which feedback from USP colleagues and stakeholders can guide content updates and future priorities.
• Lead planning, implementation, and ongoing management of a global USP Regulators Forum designed to facilitate dialogue among regulatory authorities on pharmaceutical quality topics, support knowledge exchange, and strengthen engagement with USP standards and scientific leadership.
• Provide targeted country-level support as assigned.

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:

• Bachelor’s degree required in relevant field (Life Sciences, Public Policy, Public Health, Political Science, Law, Pharmacy, Medicine, etc.).
• Eight (8) years of experience working in regulatory intelligence, regulatory affairs, public policy, or public health that includes experience working with international teams.
• Prior experience working for a science-based organization related to public health or life sciences. (e.g., NGOs, government, non-profit organization, or industry/private sector organizations.)
• Experience with and knowledge of regulatory policy making processes and analysis, including researching writing policy briefs, policy positions and other tools.
• Experience developing evidence-based policy positions, including demonstrated ability to translate scientific or regulatory information into clear, accurate and understandable content tailored to a variety of audiences.
• Excellent communication, presentation, and interpersonal skills, as well as experience communicating across cultures.
• Strong analytical and writing skills, with the ability to synthesize and report complex information, and to develop applicable strategies to align with expected outcomes.
• Project management and organizational skills, as well as ability to adapt to internal and external changes.

Additional Desired Preferences

• Advanced degree (Life Sciences, Public Policy, Public Health, Political Science, Law, Pharmacy, Medicine, etc.) or other related field preferred.
• Experience working in a matrixed organization.
• Expertise in conducting literature searches and evidence-based reviews, soliciting expert opinion through various methods, and writing/editing sound scientific reports on a wide variety of topics and issues related to public health and public policy.
• Ability to influence and drive cross-functional initiatives without direct authority.
• Familiarity with pharmaceutical quality standards and their application in regulatory or laboratory settings.

Supervisory Responsibilities

None, this is an individual contributor role.

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 $126,250.00 - $171,578.00 annually.

Target Annual Bonus: % Varies based on level of role.

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

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