Regulatory Officer (25 Positions) at Pharmacy and Poisons Board

Duties and Responsibilities: 

• Receiving, screening and undertaking dossier assessment as well as review of variation and retention applications of health products and technologies.
• Receiving and screening applications for licensing of premises as well as undertake inspections of premises, and medical products against good practices (GxP), laws, regulations, and guidelines. 
• Receiving and investigating of market complaints, conducting sampling of medical products based on procedures, communicating, enforcingand tracking of regulatory actions.
• Receiving, screening and reviewing of clinical trial applications as well as inspection of clinical trial studies and sites. 
• Collecting, analyzing, and monitoring of safety reports, or any other reports on medical products related problems. 
• Receiving and processing of applications for licensing of pharmacy practitioners and premises
• Receiving, testing, and evaluating samples in adherence to established guidelines, standards, and procedures. 
• Implementing established quality management system and benefit-risk strategy in regulatory decision making with regards to regulation of health products and 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 Bachelor’s degree in Pharmacy from a recognized university.
• Be registered by the Pharmacy and Poisons Board, Kenya. 
• Be proficient in computer knowledge and skills.
• Have good analytical and communication skills.
• Fulfil the requirements of Chapter Six of the constitution.