Regulatory Officers - 22 Posts at Pharmacy and Poisons Board

Job Purpose

The position is responsible for the day-to-day regulatory activities of implementing standards, procedures, and guidelines to ensure the quality, safety, and efficacy of health products and technologies, and that pharmacy professionals are competent and fit to practice.

Duties and Responsibilities

• Receiving, screening, and undertaking dossier assessment, as well as reviewing variation and retention applications of health products and technologies.
• Receiving and screening applications for licensing of premises, as well as undertaking inspections of premises and medical products against good practices (GxP), laws, regulations, and guidelines.
• Receiving and investigating market complaints, conducting sampling of medical products, communicating, enforcing, and tracking regulatory actions.
• Receiving, screening, and reviewing of clinical trial applications, as well as inspecting clinical trial studies and sites.
• Collecting, analyzing, and monitoring safety reports, or any other reports on medical product-related problems.
• Receiving and processing applications for licensing of pharmacy practitioners and premises.
• Receiving, testing, and evaluating samples in adherence to established guidelines, standards, and procedures.
• Implementing the established Quality Management System (QMS) and benefit-risk strategy in regulatory decision-making regarding the regulation of health products, technologies, and pharmacy practice.
• Receiving and screening applications for lot release of vaccines and biologicals.

Person Specifications

For appointment to this grade, a candidate must:

• Have a Bachelor’s degree in Pharmacy from a recognized university.
• Have a valid practising license from the Pharmacy and Poisons Board, Kenya.
• Have a valid membership with the Pharmaceutical Society of Kenya.
• Be proficient in computer knowledge and skills.
• Have good analytical and communication skills.
• Fulfil the requirements of Chapter Six of the Constitution.