Background information about the job or company (e.g., role context, company overview)

Kenya Medical Supplies Authority (KEMSA) is a state corporation under the Ministry of Health established under the KEMSA Act 2013 whose mandate is: Procure, warehouse and distribute drugs and medical supplies for prescribed public health programs, the national strategic stock reserve, prescribed essential health packages and national referral hospitals ...

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.

Responsibilities or duties

• Ensure that 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 by KEMSA.
• Conduct internal and external audits and inspections to assess compliance with Good Manufacturing Practices (GMP), Good Storage & Distribution Practices (GSDP) as applicable, and other relevant standards.
• Develop and implement regulatory strategies for the approval, registration, and maintenance of products in KEMSA’s portfolio, ensuring minimal disruption to supply chain operations.
• Provide advice to internal stakeholders on regulatory matters, including the impact of regulatory changes on operations, supply chains, and product lines.
• Act as the liaison between KEMSA and regulatory authorities, managing relationships with government agencies, industry bodies, and other key stakeholders to facilitate regulatory approvals.
• Represent KEMSA in regulatory meetings, forums, and industry working groups to stay informed on emerging regulatory trends and advocate for favorable policy changes.
• Identify potential regulatory risks that could impact product availability or organizational compliance, and develop strategies to mitigate those risks.
• Ensure the proper handling of customer complaints related to product quality and safety by coordinating investigations and ensuring compliance with regulatory reporting requirements.
• Train and mentor internal staff on regulatory requirements, quality assurance processes, and relevant SOPs to enhance organizational compliance and product safety.
• Develop training materials and conduct workshops on regulatory affairs and product compliance for different departments.
• Maintain detailed records of regulatory submissions, approvals, and compliance audits.
• Prepare regular reports for senior management on regulatory activities, compliance status, and research findings to inform decision-making.
• Implement proper management of controlled and dangerous drugs in line with the existing Laws
• Superintend the assigned KEMSA Warehouse as and when required in line with Cap 244, the Pharmacy and Poisons Act.

Qualifications or requirements (e.g., education, skills)

Requirements for Appointment

For appointment to this grade, an officer must have: -

• 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 comparable position.
• Bachelor's Degree 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; and
• Shown merit and ability as reflected in work performance and results

Experience needed

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 comparable position.

Any other provided details (e.g., benefits, work environment, team info, or additional notes)

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• Ensure that 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 by KEMSA.
• Conduct internal and external audits and inspections to assess compliance with Good Manufacturing Practices (GMP), Good Storage & Distribution Practices (GSDP) as applicable, and other relevant standards.
• Develop and implement regulatory strategies for the approval, registration, and maintenance of products in KEMSA’s portfolio, ensuring minimal disruption to supply chain operations.
• Provide advice to internal stakeholders on regulatory matters, including the impact of regulatory changes on operations, supply chains, and product lines.
• Act as the liaison between KEMSA and regulatory authorities, managing relationships with government agencies, industry bodies, and other key stakeholders to facilitate regulatory approvals.
• Represent KEMSA in regulatory meetings, forums, and industry working groups to stay informed on emerging regulatory trends and advocate for favorable policy changes.
• Identify potential regulatory risks that could impact product availability or organizational compliance, and develop strategies to mitigate those risks.
• Ensure the proper handling of customer complaints related to product quality and safety by coordinating investigations and ensuring compliance with regulatory reporting requirements.
• Train and mentor internal staff on regulatory requirements, quality assurance processes, and relevant SOPs to enhance organizational compliance and product safety.
• Develop training materials and conduct workshops on regulatory affairs and product compliance for different departments.
• Maintain detailed records of regulatory submissions, approvals, and compliance audits.
• Prepare regular reports for senior management on regulatory activities, compliance status, and research findings to inform decision-making.
• Implement proper management of controlled and dangerous drugs in line with the existing Laws
• Superintend the assigned KEMSA Warehouse as and when required in line with Cap 244, the Pharmacy and Poisons Act.

• Proficiency in computer applications

• Bachelor's Degree 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;