Nyanza Reproductive Health Society (NRHS) is a Kenyan non-profit organization established in 2002, with its headquarters in Kisumu. NRHS is dedicated to improving public health through research, evidence-based programming, capacity building, education and advocacy. NRHS has extensive experience in conducting research and implementing programmes in HIV prevention, care and treatment, sexual and reproductive health, and other public health interventions.
As part of its ongoing research activities, NRHS is undertaking a clinical research study to evaluate the efficacy and safety of a once-monthly oral HIV pre-exposure prophylaxis pill. The study aims to contribute to the development of additional HIV prevention options through the evaluation of this investigational medication. The research will be conducted in Kisumu, and NRHS seeks highly qualified and experienced candidates to fill the following positions:
JOB TITLE: Regulatory Officer (1 position)
Duties & Responsibilities:
- Coordinate preparation and submission of clinical trial applications, protocol amendments, renewals and regulatory correspondence to the relevant ethics committees and authorities.
- Maintain current regulatory approvals, essential documents, delegation records and submission trackers, ensuring accurate version control and inspection readiness.
- Monitor regulatory obligations and submission deadlines, including study progress reports, continuing reviews and close-out notifications.
- Coordinate preparation and timely submission of safety reports, protocol deviations and other reportable events with the Principal Investigator and study safety team.
- Liaise with the Pharmacy and Poisons Board (PPB), ethics committees, NACOSTI and study partners to address queries and follow up on approvals.
- Support monitoring visits, audits and regulatory inspections, track findings and follow up on agreed corrective and preventive actions (CAPA).
- Review study documents and operational changes for regulatory implications and advise study teams on GCP and approval conditions.
Qualifications and competencies
- Degree in health sciences, biomedical sciences, pharmacy or another relevant discipline.
- Additional training in regulatory affairs.
- Demonstrable experience working in clinical trials, including regulatory submissions and ethics approval processes.
- Working knowledge of Good Clinical Practice (GCP), applicable Kenyan clinical trial requirements and research ethics.
- Experience maintaining essential trial documents, regulatory trackers and version-controlled study records.
- Strong organizational, written communication and follow-up skills, with attention to deadlines and confidentiality.
APPLICATIONS SHOULD INCLUDE:
- A current CV detailing qualifications and relevant work experience, with telephone and e-mail contact information.
- Names, telephone numbers and e-mail contacts of at least 2 professional referees.
Apply via https://forms.gle/82H7cw91QduciJ8C7. Applications close on 25th November 2026. Only shortlisted candidates will be contacted.
For inquiries, feel free to reach us via humanresources@nrhskenya.org
UNIM Research and Training Center
Lumumba Sub County Hospital Compound
P.O. Box 1764-40100
Kisumu, Kenya
Tel: 057 2024065
Mobile: +254 733 912605