Senior International Regulatory Intelligence Manager

Who is USP?
The U.S. Pharmacopeial Convention (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 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.
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—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, 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.

Brief Job Overview

The Senior International Regulatory Intelligence Manager will lead the development and execution of an international regulatory intelligence program that will inform enterprise decision-making; support regulatory interactions on policy issues; and identify opportunities or risks that may impact USP’s mission. While this role is an individual contributor, this professional but will be responsible for leading a collaborative effort across USP’s organization to build and engage staff and leadership in a program that supports USP’s current work and inform future strategy. Deliverables include frequent written analysis, and the effective use of current digital and technology tools to identify relevant regulatory trends. This position will also address specific policy and regulatory research needs and provide pertinent insights and analysis towards identifying opportunities to improve medicine quality.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The Senior Manager, International Regulatory Intelligence has the following responsibilities:

• Formalize, manage and execute an international regulatory intelligence program to undertake research and inform the organization of critical policy and regulatory developments relevant to USP’s mission.
• Effectively lead a cross-functional team or working group of internal USP experts in the execution of this process.
• Identify meaningful opportunities for USP to comment on international regulatory policy dockets aligned with our mission and priorities, and coordinate regional and other colleagues in the development of such comments.
• Provide analysis and insights that deepen USP’s understanding of international regulatory environments for medicines as well as relevant quality paradigm shifts relevant to USP’s work.
• Manage commissioned or outsourced work, as needed, to support the regulatory intelligence portfolio.
• Specific focus is on collecting and synthesizing international perspectives on existing and evolving regulatory policy positions related to USP’s mission. This involves an understanding of the diversity of healthcare systems across the globe, as well as the interplay between US and ex-US policy. This role will collaborate closely with the US Regulatory Intelligence team.
• Collaborating with public policy and regulatory affairs colleagues located globally, identify key trends that will inform USP’s policy priorities and conduct analysis of opportunities and risks.
• Play an active role in supporting the execution of key projects within the International Government & Regulatory Affairs Team and broader Global External Affairs Team.
• Outputs and deliverables will include frequent internally published analysis of key in