The Principal Research & Regulatory Affairs Officer at the Kenya Medical Supplies Authority (KEMSA) is responsible for overseeing regulatory compliance, product registration, and quality assurance processes. This role ensures adherence to applicable laws, manages regulatory submissions, supports research and audits, and coordinates stakeholder engagement to guarantee a safe, compliant, and uninterrupted supply of healthcare products.
Purpose Statement
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 product registration process, including submission of product dossiers, license renewals, 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 distribution.
- 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, including the impact of regulatory changes on operations and product lines.
- Act as the liaison between KEMSA and regulatory authorities, managing relationships with government agencies and industry bodies.
- Represent KEMSA in regulatory meetings, forums, and industry working groups to stay informed on emerging trends and advocate for policy changes.
- Identify potential regulatory risks and develop strategies to mitigate impacts on product availability.
- Ensure proper handling of customer complaints related to product quality and safety by coordinating investigations and compliance reporting.
- Train and mentor staff on regulatory requirements, quality assurance processes, and relevant SOPs.
- Implement proper management of controlled and dangerous drugs in line with existing laws.
- Superintend assigned KEMSA warehouses as required in line with Cap 244, the Pharmacy and Poisons Act.
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
Interested and qualified candidates should send their applications addressed to the address below by 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
Note: Only shortlisted candidates will be contacted for interviews.
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