Senior International Regulatory Affairs Manager

USP•Rockville, MD

About The Position

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 than 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.

Requirements

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.

Nice To Haves

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.

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.
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.
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.