Director, US Regulatory Engagement (1184-679)

Location
Rockville, Maryland, United States
Posted
Sep 07, 2018
Closes
Sep 28, 2018
Function
Executive, Director
Hours
Full Time

The professional in this role will lead engagement with US federal and state government agencies and officials at a regulatory policy level to promote and advance quality in medicines, foods, dietary supplements, and healthcare quality. The position will serve as USP’s key representative on policy and regulatory science interactions with the U.S. Food and Drug Administration (FDA) and other regulatory authorities, and will be responsible for leading the development and operation of a comprehensive and sustained engagement strategy to enhance and expand the collaborative relationship between USP and U.S. regulatory agencies. Serving as a U.S. regulatory policy expert, the role will establish and oversee USP’s regulatory intelligence function, directing the institution and implementation of systems/processes to monitor the regulatory environment for changes that may have an impact on USP’s standards, programs, and goals. In this capacity the function will have responsibility to identify and advocate for regulatory policies that support development of effective practices and processes that advance USP’s public health objectives, and to monitor, evaluate and provide strategic analyses of regulatory and legislative developments to inform enterprise decision making and respond to regulatory change. She/he will be a member of the USP US Public Policy and Regulatory Affairs Leadership team; work closely with peers leading the US Public Policy, and US Government Affairs groups

Roles and Responsibilities
  • Lead, facilitate, and support regulatory engagement activities and interactions, providing advisement and guidance on FDA organization, process, and personnel, as well as supportive resources (position papers, analysis) for these interactions.
  • Build relationships with key regulatory decision makers, and develop and disseminate best practice within USP for specific regulatory program areas. Establish networks with FDA and other regulatory bodies, and industry associations.
  • Attend regulatory policy conferences and forums including FDA public meetings/hearings, and communicate key insights and intelligence to USP colleagues and leadership.
  • Ensure delivery of timely regulatory intelligence to a broad range of internal USP stakeholders highlighting emerging opportunities/risks, and providing an assessment of organizational impact. Develop training, knowledge sharing, reports and other modes of communication to advance organizational regulatory expertise and decision making. Assist in communicating and presenting regulatory best-practices across the organization.
  • Anticipate, identify, track, interpret, and communicate regulatory trends, including progress on implementation of recent FDA reform legislation through comprehension of new and revised regulatory guidelines, regulations, and laws that may have an impact on USP’s products and regulatory business processes.
  • Develop analysis of recent FDA guidance, regulation, and legislation. Develop strategic assessments of external regulatory changes and work with subject matter experts within USP to support the decision-making process to understand and prioritize the regulatory risks & opportunities, develop strategies/ positions and drive for appropriate action(s) relevant to USP’s strategic focus.
  • Manage internal cross-disciplinary working groups to align USP positions and actions on various regulatory issues. Coordinate with USP subject-matter experts to develop USP comments to the docket, and guide documents through internal process for commenting and input.
  • Conduct research and landscape analysis projects on select topics and develop issue briefs or policy positions.
  • Develop and communicate cohesive and consistent USP regulatory positions helping to ensure consistent USP messaging with regulators, in coordination and alignment with US Government Affairs, and US Public Policy.
  Basic Qualifications
  • Bachelor’s degree in life sciences, law, public health or other relevant field
  • Minimum of seven (7) years of significant regulatory experience and/or related experience working in government affairs or public policy in a healthcare-related, life science industry or health policy organization. Health & Human Services regulatory/policy experience required (e.g. HHS/CMS/FDA), with demonstrated record of working with the US FDA. 
Preferred Qualifications

 

  • Ability to understand and interprets complex scientific issues as it relates to regulatory requirements, regulatory intelligence, policy and strategy.
  • Solid knowledge of regulatory strategy and regulatory affairs and ability to translate implications across the organization to proactively identifies regulatory issues, and appropriate solutions and strategies.
  • Demonstrated success in working in a matrixed organization, coordinating across functional areas and leading with limited authority.
  • Familiarity with global public health issues is an advantage.
  • Management of consultancy engagements.
  • Demonstrated skills at building sustainable relationships with government officials and policy makers.
  • Track record demonstrating commitment to public health.
  • Excellent written and verbal communications skills.

USP offers an impressive benefits package, including:

  • Generous paid time off – 13 paid holidays, 10 sick days and 15 vacation days per year to start
  • An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
  • Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods 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. 

Job Location Rockville, Maryland, United States Position Type Full-Time/Regular

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