Principal, Research & Regulatory Affairs Officer

Role Purpose

To oversee regulatory compliance, product registration, and quality assurance processes by ensuring adherence to applicable laws, managing regulatory submissions, supporting research and audits, and coordinating stakeholder engagement to ensure safe, compliant, and uninterrupted supply of healthcare products.

Duties and Responsibilities

• Ensure KEMSA complies with all relevant laws, guidelines, and standards set by regulatory bodies such as the Pharmacy and Poisons Board (PPB), Kenya Bureau of Standards (KEBS), and other national and international authorities.
• Prepare and submit regulatory documentation for approval of pharmaceuticals, medical devices, nutritional supplements, and other healthcare products procured and distributed by KEMSA.
• Manage the process of product registration, including submission of product dossiers, renewals of licenses, and ensuring products meet regulatory approval for importation, storage, and distribution.
• Maintain accurate records of all registered products and their regulatory status, ensuring timely renewals and updates.
• Conduct research on regulatory requirements, market trends, and innovations in pharmaceuticals, medical devices, and healthcare technologies to support decision-making and strategic planning.
• Analyze data from quality assurance processes, clinical trials, or post-market surveillance to ensure products meet safety and efficacy standards.
• Collaborate with the Quality Assurance team to ensure that all products and services meet the required quality standards before they are distributed.
• Conduct internal and external audits and inspections to assess compliance with Good Manufacturing Practices (GMP), Good Storage & Distribution Practices (GSDP), and other relevant standards.
• Develop and implement regulatory strategies for the approval, registration, and maintenance of products in KEMSA’s portfolio.
• Provide advice to internal stakeholders on regulatory matters and the impact of changes on operations and supply chains.
• Act as the liaison between KEMSA and regulatory authorities, managing relationships with government agencies and industry bodies.
• Identify potential regulatory risks and develop mitigation strategies.
• Handle customer complaints related to product quality and safety by coordinating investigations.
• Train and mentor internal staff on regulatory requirements, quality assurance processes, and relevant SOPs.
• Maintain detailed records of regulatory submissions, approvals, and compliance audits.
• Prepare regular reports for senior management on regulatory activities and compliance status.
• Implement management of controlled and dangerous drugs in line with existing laws.
• Superintend assigned KEMSA Warehouses as required in line with the Pharmacy and Poisons Act (Cap 244).

Requirements for Appointment

• Cumulative service period of nine (9) years’ work experience, three (3) of which must have been at the grade of Senior Research and Regulatory Affairs Officer or in a comparable position.
• Bachelor's Degree in Pharmacy, Bio-medical Engineering, Chemistry, Biochemistry, Analytical Chemistry, Medical Laboratory, Microbiology, Nursing, Nutrition, Public Health, or its equivalent qualification from a recognized institution.
• Membership to a professional body where applicable.
• Management course certificate lasting not less than four (4) weeks from a recognized institution.
• Proficiency in computer applications.
• Shown merit and ability as reflected in work performance and results.

How to Apply

Applications should be addressed to the Chief Executive Officer at the address below. Deadline for applications is 6th May, 2026 at 5:00 p.m. (East Africa Time).

Chief Executive Officer,
Kenya Medical Supplies Authority
P.O BOX 47715-00100, NAIROBI
Attn: Director, Corporate Services