U.S. Pharmacopeial Convention Jobs

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The U.S. Pharmacopeial Convention (USP) Senior Regulatory Policy Manager in Rockville, Maryland

Description

The U.S. Pharmacopeial Convention (USP) is a global nonprofit organization focused on improving global public health. We do this through 1) Science-based public quality standards; 2) Programs that enhance the capabilities of industry and government agencies to ensure the quality of medicines, supplements and foods; and 3) Advocacy initiatives that create broader awareness about medicine quality to help shape policy reforms and investment in quality.

The Senior Regulatory Policy Manager is a hands-on, individual contributor role where the incumbent is responsible for providing the organization with insights into, and analysis of, regulatory policy developments related to the quality of medicines, dietary supplements, and a more resilient global supply chain for medical products from key U.S. government agencies. The Senior Regulatory Policy Manager will play an important role in strengthening USP’s comprehensive, structured, and sustained approach to identify, monitor, evaluate, communicate, and prioritize regulatory policy developments and collaborative engagement between USP and U.S. regulatory agencies. The Senior Regulatory Policy Manager will serve as the lead staff responsible for coordinating and drafting USP’s comment letters in response to draft guidance documents and/or proposed rules of federal agencies, including but not limited to the Food and Drug Administration (FDA). The successful candidate will support organizational coordination regarding regulatory developments to inform enterprise decision-making and improve the operational aspect of USP’s regulatory engagements.

Regulatory policy content generated by the Senior Regulatory Policy Manager will provide the substantive basis and/or support for advocacy activities to advance the supply of quality medicines in the US and will be utilized in dialogues with policy-makers and influencers. It will be delivered in multiple forums including through public comments, policy-maker dialogues, and various communications channels. Synthesizing and explaining the technical and scientific rationale underlying USP’s policy perspectives will be essential.

The successful candidate will be joining a dynamic team that is focused on stakeholder engagement, evidence development, communications, and policy and will work closely with and foster collaboration among team members and across divisions, especially with USP’s regulatory operations team members. This position reports to the Director, Regulatory and Public Policy Development, and coordinates closely with colleagues across the USP Global External Affairs and USP organization.

Roles and Responsibilities

  • Support the development and execution of an evidence-based, stakeholder-informed, regulatory policy agenda consistent with USP’s mission.

  • Identify regulatory commenting opportunities and lead the process for the drafting of comments for submission to regulatory dockets.

  • Build and maintain relationships, networks, and collaborations with key regulatory policy stakeholders.

  • Track and prioritize issues of critical importance to U.S. regulatory agencies with USP strategies and goals and identify potential areas of collaboration and new areas for engagement with agencies and other stakeholders.

  • Coordinate with USP colleagues to understand and monitor evolving regulatory policy trends and interventions, both domestically and internationally, and work with internal stakeholders to identify opportunities and risks for the global community.

  • Coordinate with USP colleagues to communicate implications of regulatory policy developments on compendial policy and standards development and be well-informed about internal and external changes, trends, developments, and other dynamics relevant to the regulatory environment that may impact USP’s standards, programs, and goals.

  • Support internal cross-disciplinary working groups with relevant regulatory policy expertise to inform USP positions and actions on various regulatory issues.

  • Support key regulatory engagement functions such as the FDA-USP Quarterly Meeting and other dialogues with health and science regulatory agencies in the U.S.

  • May include other responsibilities as assigned.

Basic Qualifications

Education

  • Bachelor’s degree required in relevant field (Public Policy, Public Health, Political Science, Law, Pharmacy, Medicine, Life Sciences, etc.)

Experience

  • Eight (8) years of experience in public policy, public health, regulatory affairs, or a combination of the three, including production of a range of materials in various delivery formats that articulate perspectives on public policy topics.

  • Prior experience working for a regulatory policy-based organization, preferably related to public health or pharmaceuticals, a non-governmental organization (NGO), non-profit organization, government, or private sector organization.

  • Experience with and knowledge of policy-making processes and policy and regulatory analysis.

  • Experience working within or interacting with U.S. government regulatory agencies.

  • Solid knowledge of regulatory strategy and regulatory affairs and ability to translate implications across the organization to proactively identify opportunities and risks as well appropriate solutions and strategies.

  • Experience drafting comment letters in response to draft guidance documents and/or proposed rules of U.S. federal agencies.

Skills Sought

  • Excellent content analysis and synthesis skills.

  • Well-developed and strong organizational, interpersonal communications, presentation, facilitation, writing, and listening skills.

  • Strong thought leadership and the ability to synthesize and report complex information, think broadly, and develop applicable strategies to align with expected outcomes.

  • High-level and systematic organizational skills, the ability to set priorities, and to cope with change.

  • Ability to effectively engage with partners and support strategic initiatives or a business function; includes implementing strategy for a key function, supporting organization-wide initiative(s) or a functional group/team, and providing strategic direction to managers and directors on key organizational priorities.

  • Solution-oriented and innovative; can identify creative options for resolving issues that respond to all stakeholder interests and needs.

  • Strong strategic thinking, written, and verbal communication skills.

  • Demonstrated initiative and ability to successfully handle multiple priorities and projects in a fast-paced environment.

Preferred Qualifications

  • Advanced degree (such as J.D., Ph.D., Masters) in public policy, public health, law, pharmacy, medicine, or another related field strongly preferred.

  • Strong knowledge of FDA organization, functions, and processes.

  • Experience in compendial and product quality areas.

  • Experience with commenting processes of key international and multinational organizations.

  • Comfortable dealing with complex enterprise-wide processes, business rules, and procedures with the ability to connect to overall scientific, public policy, and regulatory goals effectively.

  • Knowledge of the life sciences industry especially in areas of regulatory affairs, manufacturing, and quality.

  • Demonstrated ability to work collaboratively in a matrixed organization.

  • Demonstrable commitment to public health/patient safety/consumer protection, familiarity with global public health issues is an advantage.

  • Ability to influence and drive initiatives without direct authority.

  • Strong project management and knowledge management experience.

  • Proactive with a sense of urgency, with proven ability to prioritize and focus on key objectives

Supervisory Responsibilities

This is an individual contributor role.

Benefits

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 are protected.

About USP

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. 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.

The following COVID-19 provisions will apply to selected candidate(s) hired:

As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

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

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