Regulatory Officer (25 Posts) at Pharmacy and Poisons Board Full Time

Duties and Responsibilities:

• Receive, screen and assess dossier of health products and technologies for variation and retention applications.
• Receive and screen premises licensing applications and conduct inspections for compliance with GxP, laws, regulations, and guidelines.
• Investigate market complaints, sample medical products, enforce and track regulatory actions.
• Receive, screen and review clinical trial applications and inspect clinical trial studies and sites.
• Collect, analyze and monitor safety reports and medical product-related problems.
• Receive and process applications for licensing of pharmacy practitioners and premises.
• Test and evaluate samples following established guidelines, standards and procedures.
• Implement quality management system and benefit-risk strategy in regulatory decision making for health products and pharmacy practice.
• Receive and screen applications for lot release of vaccines and biologicals.

Qualifications:

• Possess a Bachelor’s degree in Pharmacy from a recognized university.
• Registered by the Pharmacy and Poisons Board, Kenya.
• Proficient in computer knowledge and skills.
• Good analytical and communication skills.
• Meet the requirements of Chapter Six of the constitution.