The Senior Regulatory Systems Strengthening Manager is responsible for developing evidence-based approaches, developing and implementing USP Global Health activities on regulatory services strengthening (RSS) for pharmaceuticals, and providing assistance in activities to support thought leadership activities. The selected individual will assist the Global Health and Manufacturing Services (GHMS) division for all RSS-related activities including market authorization, governance and policy, market surveillance, with an emphasis on pharmacovigilance. The success of this role will be measured through the development of sound technical programs, support to new business, production of white papers and other content, and representation at global working groups and at conferences. The position will work collaboratively across the GHMS division.
Roles and Responsibilities
- Technical Support
- Provide technical oversight for global health projects related to RSS
- Identify, review, develop and continuously improve technical approaches to GHMS core areas to improve regulatory systems-based approaches and thought leadership
- Identify new and adjacent areas in RSS for GHMS to contribute by identifying needs, developing plans
- Prioritize and develop selected technical areas of expertise/experience/interest
- Engage with other experts on technical program impact
- Improve visibility of GHMS work by identifying conferences, writing abstracts, making presentations
- New Business Technical Inputs
- Monitor and identify areas to prioritize for technical offerings by reviewing relevant global trends and donor investments (as tracked by business development), including GFATM, World Bank, Gates, USAID, and others to identify unmet needs and propose solutions
- Liaise with the new business unit to support day-to-day needs
- Act as technical lead in developing proposals involving RSS
- Programmatic/Administrative Support
- Assist the team in donor-funded/sub-role programmatic activities relevant to regulatory systems
- Support donor engagement/prime engagement by attending/leading areas
- Mentor Role
- Mentor junior or in-country staff/students when needed
- Support onboarding of new staff who need technical orientation
- BS. in regulatory affairs, pharmaceutical sciences, chemistry, public health or related field
- Eight (8) years in designing and implementing projects that contribute to stronger health systems and improve health outcomes in low- and middle-income countries, including at least six years’ experience in regulatory system strengthening and two years of cumulative experience in pharmacovigilance
- Demonstrated experience engaging with and contributing to global pharmaceutical stakeholders and systems agenda and programs.
- Demonstrated success working effectively with multidisciplinary and international project teams.
- Established success in designing donor-funded projects in the pharmaceutical space.
- Excellent oral, written and presentation skills in English
- Ability to travel up to 25%.
- M.S. in regulatory affairs, pharmaceutical sciences, chemistry, public health or related field
- A PhD in pharmacy, pharmaceutical sciences, chemistry, public health or related field is preferred
- Direct experience with and understanding of the WHO Global Benchmarking Tool
- Excellent oral, written and presentation skills in French.
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 1 st , 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.