Regulatory Officer (25 Positions)

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.

IMPORTANT NOTICEApplication Procedure
Quick Guiding Steps

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