Summary of the Position
The Senior Technical Advisor, Regulatory System Strengthening and Laboratory Strengthening (RSS and LS) is a key technical leadership position within the anticipated Promoting the Quality of Medicines Plus (PQM+) program. As the lead for the PQM+ center of excellence for Regulatory System Strengthening and Laboratory Strengthening, the Advisor provides technical oversight and direction to all global implementation activities related to the program’s objectives related to sustainable regulatory and laboratory system strengthening including: strengthening of regional and country regulatory systems (with focus on Market Authorization, Post Marketing Surveillance and Laboratory Strengthening), advancing enabling governance and transparency, supporting regulatory harmonization and sustainable resource mobilization for regulatory systems. Additionally, he/she acts as a highly-visible thought leader, interfacing with global experts and leaders in the area of health and regulatory system strengthening.
Roles and Responsibilities
- Define strategy and approach for technical assistance delivery across all areas related to regulatory and laboratory system strengthening, ensuring alignment with international best-practices and with already defined USP technical approaches, where relevant. Key areas include the following:
- Advancing enabling policy, governance, transparency and cross-sector/ stakeholder coordination
- Strengthening of regulatory functions, including market authorization and post marketing surveillance
- Strengthening of national quality control laboratories to reach internationally-recognized quality standards such as ISO17025 and WHO pre-qualification
- Supporting sustainable resource mobilization for laboratories and national regulatory authorities (NRAs), through, for example, implementation of strategic/ business planning, setting fee schedules, and risk-based resource allocation
- Co-lead, with Regional Deputy Directors for Africa and Asia and key partners, development, deployment and continuous improvement of strategy and approaches to advance regulatory harmonization across respective regions
- Work closely with PQM+ Senior Workforce Development Advisor to promote sustainable development of regulatory workforce, including through development of University curricula and in-service trainings and other capacity development programs
- Ensure consistent, high-quality and results-driven technical assistance provision for all global activities under his/ her technical scope, identifying and delivering continuous improvements based on new evidence/ information and programmatic experience
- Lead RSS and LS work group, comprised of regional technical advisors and experts in workforce development, strategic planning experts and key partners (as needed), directed to help inform technical approach and continuous improvement
- Provide oversight for technical staff, regional/ local partners and consultants involved in delivery of regulatory and laboratory support, ensuring strong development trajectory for staff and regional/ local partners
- Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports
- Oversee resource deployment for his/her area, with the objective of maximizing efficiency and impact and of progressively developing staff and local/regional partners
- Act as globally visible thought leader in area, actively advancing and deploying relevant knowledge based on programmatic experience and identified relevant research topics PQM+ externally in relevant forums
- Interfaces regularly with key global external stakeholders/ groups in relevant areas including, with WHO pre-qualification team, regulatory forums/authorities, and other leaders in health system strengthening
- Extensive experience [8 + years] in regulatory affairs specifically medicines registration, inspection, and quality post market surveillance in low- and middle-income countries.
- Substantive [8+ years] people management experience and skills , including ability to seamlessly manage virtual teams
- Demonstrated experience in developing and implementing regulatory systems strengthening interventions obtained from working with national regulatory authority or from the pharmaceutical industry
- Knowledge of international regulatory guidelines (e.g., WHO, ICH, PIC/S, EMA, FDA, ISO, etc.)
- Working experience with assessment tools (e.g., WHO Global Benchmarking Tool – GBT) to evaluate key functions of a medicines regulatory authority
- BA/BS degree in regulatory affairs, pharmaceutical sciences, public health or related field
- Demonstrated thought leadership in regulatory systems strengthening
- Strong written (especially technical writing) and oral communication skills
- Willingness to travel at least 25% of the time.
- Advanced degree in pharmaceutical sciences, public health or related field
- US FDA or similar work experience
- Work experience in both Asia and Africa
- Direct experience implementing USAID-funded programs
- Fluency in French
Reports will scale with program growth and will include relevant technical staff serving non presence countries – with nature of reporting line (solid v. dotted) varying by location
USP offers an impressive benefits package, including:
- Generous paid time off – 14 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. _