Description
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 workan 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 USPs mission. While this role is an individual contributor, this professional but will be responsible for leading a collaborative effort across USPs organization to build and engage staff and leadership in a program that supports USPs 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 USPs 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 USPs understanding of international regulatory environments for medicines as well as relevant quality paradigm shifts relevant to USPs 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 USPs 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 USPs 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 international regulatory trends and implications for USP.
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:
Bachelors 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 pharmaceuticals. Examples include NGOs, government, non-profit organization, or industry/private sector organizations. Experience with perspectives across sectors / disciplines in healthcare ecosystems is preferred.
Experience utilizing and pro-active embracement of digital and technology tools to identify regulatory trends in key countries.
Experience with and knowledge of regulatory policy making processes and analysis, including researching writing policy briefs, policy positions and other tools.
Experience developing statements for the record, formal comment letters, and evidence-based policy position statements.
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.
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 $121,000.00 Mid.$153,500.00 annually.
Target Annual Bonus: % Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidates skill set, experience, qualifications, equity, and other job-related reasons.
Note: 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.
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 contractors legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Ext. Affairs, Regulatory, & Communications
Job Type Full-Time