Regulatory Associate Consultant at US Pharmacopeial Convention (USP)

Reports to: Chief of Party-Nigeria, USP PQM

Summary of the Position

• Under the general supervision of the Chief of Party-Nigeria, the Regulatory Associate Consultant will serve as the technical officer responsible for planning, orcanizinq, monitoring, activities that support PQM's efforts to strengthen medicine regulatory activities of the National Agency for Food and Drug Administration and Control (NAFDAC).
• The Consultant will also support PQM's projects that involve strengthening the regulatory compliance ofthe pharmaceutical manufacturing industry in Nigeria.

Roles and Responsibilities

• Provides technical assistance, as needed, in support of PQM activities to improve medicines quality regulatory activities in Nigeria, with specific work requested by program partners and approved by PQM.
• Provides technical advice to NAFDAC management and staff, particularly on medicines regulation and pharmaceutical product assessment through the PQM program.
• Maintains partnerships to ensure continuity of external technical advice and support, which includes the goal of establishing a forum of experts, and coordinates ongoing activities by major regulatory agencies in Nigeria.
• Manages specific PQM project activities as assigned by the PQM Chief of Party-Nigeria.
• Ensures that all program work for the PQM office is completed by country partners on time and on budget.
• Provides assistance in the formulation of guidelines for medicines regulation to improve the safety and quality of medicines in line with the national regulatory system.
• Prepares quarterly and annual activity reports (through COP) and submits them to USP PQM Headquarters, USAID/Nigeria, and other country partners within the set parameters of the contract.
• Serves as liaison officer to partners and regulatory authorities such as WHO, NAFDAC, Federal Ministry of Health, and others. Performs other duties as requested.

Minimum Requirements
Education

• Bachelor of Science degree in pharmacy or chemistry required

Experience

• Relevant work experience in the food, medicines, or drug regulatory area within the pharmaceutical industry
• Experience in project development and implementation. Relevant work experience within government medicines regulatory agencies a plus

Knowledge, Skills and Abilities

• Knowledge of Nigeria's infrastructure related to medicines regulation and quality assurance and control systems.
• Knowledge of pharmaceutical regulations; familiarity of WHO Pre-qualification Programme or good manufacturing requirements. Excellent verbal and written communication skills.
• Ability to influence without direct authority Results-driven with demonstrated successful outcomes; organized and able to effectively follow up on priority activities.
• Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
• Ability to handle multiple priorities in a fast-paced environment