Technical Advisor, Regulatory Systems Strengthening (RSS) at US Pharmacopeial Convention (USP)

Summary of the Position

• The Technical Advisor, Regulatory Systems Strengthening (RSS) will provide technical assistance to the Pharmacists Council of Nigeria (PCN) to build their capacity to regulate the practice of Community Pharmacies and Patent and Proprietary Medicines Vendors (PPMVs) on the quality assurance of the aspects of medical product supply chain in Nigeria.
• He/She must possess a deep understanding of pharmaceutical regulatory environment in low income and middle-income countries.
• As the focal point for PQM+ Nigeria in RSS, the Technical Advisor provides technical oversight related to the program’s objective of strengthening regulatory capacity in registration, inspections, post-marketing surveillance, and other regulatory functions associated with quality assurance.
• Additionally, he/ she acts as a recognized leader, interfacing with PCN and stakeholders.

Roles and Responsibilities

• Provides technical oversight of activities to support Pharmacists Council of Nigeria (PCN)
• Provide technical supervision of the state level activity to strengthen the regulatory and quality assurance systems
• Serve as Point of contact for PQM+ program at Pharmacists Council of Nigeria (PCN)
• Technical reports and papers for publication in reputable journals assigned by technical leads
• Mobilize community pharmacies and patent medicines shops and their operators to participate in agreed activities
• Participate in outlined activities to enhance the quality of medical products, practice, premises/shops, and services offered
• Implement agreed task at state level to improve the regulatory and quality assurance systems (RQAS
• Engage key state level actors in the medical products regulatory and quality assurance system sector paying close attention to retail aspect
• Collect data and information required for an in-depth understanding of the strength, gaps, weakness and opportunities in the retail medical products space
• Follow up with the states on agreed action plans, activities or decision
• Attend meetings requiring their presence
• Prepare details reports of activities conducted
• Supports the work and efforts of the Technical Director and the center of excellence to develop technical documents on regulatory system strengthening.
• Keep abreast of the latest regulatory trends and WHO guidance
• Represents the organization in local and regional forums on RSS
• Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports
• Collect data for MEL indicators from activities implemented with the state level inspectors, community pharmacy and patent medicines vendors, other stakeholders on retail regulatory and quality assurance systems.

Supervisory Responsibilities:

• Reports will scale with program growth and will include relevant technical staff.

Basic Qualifications

• 8 + years of relative experience in regulatory system strengthening related work preferably with organizations such as USAID, World Health Organization or any of the UN agencies.
• Bachelor's Degree in Pharmacy, Pharmaceutical Science, Chemistry, Engineering or Science related field of study required
• Subject matter expert in any of the following national regulatory systems, pharmaceutical policy/regulations, market authorization, post-market surveillance, licensing or inspections.
• Knowledge of international regulatory guidelines
• Demonstrated experience in implementing regulatory systems
• Strong written (especially technical writing) and oral communication skills
• Willingness to travel at least 25% of the time.

Preferred Qualifications:

• Direct experience implementing USAID-funded programs
• 5+ years of people management experience and skills
• Direct experience with and understanding of WHO global benchmarking tool
• Experience in WHO GBT and PIC/S.

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.