Administrative and Regulatory Affairs Officer

Join KEMRI as an Administrative and Regulatory Affairs Officer and play a pivotal role in health research! Use your expertise to manage regulatory submissions, streamline documentation, and drive operational excellence. With a Bachelor’s degree and 1-2 years’ experience, you’ll support clinical trials, engage stakeholders, and ensure compliance. Ready to make an impact? Apply now!

The Kenya Medical Research Institute (KEMRI) is a state corporation established through the Science and Technology (Amendment) Act of 1979, which has since been amended to Science, Technology and Innovation Act 2013 as the national body responsible for carrying out health research in Kenya.

Administrative And Regulatory Affairs Officer

Key responsibilities

• Manage and optimize the Site Manager’s calendar, meeting schedule, and daily priorities, ensuring protected time for high-value operational, supervisory, and strategic tasks while proactively flagging scheduling conflicts and approaching deadlines
• Maintain structured task tracking systems and dashboards across all active deliverables, action points, and deadlines; develop automated reminders and accountability tools using Excel, Asana, Trello, or equivalent platforms
• Prepare meeting agendas, compile background documents, take minutes, and ensure follow-up for internal coordination meetings, team meetings, advisory board meetings, stakeholder engagements, and site visits
• Coordinate logistics for all meetings, delegation visits, and all-team gatherings, including travel planning, expense reporting, document preparation, and forward-looking scheduling
• Track all regulatory submissions and approvals for IRBs, Ethics Committees, PPB, NACOSTI, and KEMRI ERC; monitor timelines, expiries, renewals, protocol amendments, continuing review submissions, re-consents, and safety reports across studies
• Maintain a live regulatory and operational tracker/dashboard with status updates for each study and regulatory body, ensuring timely circulation of updates, meeting outcomes, and institutional communications across teams
• Support preparation and compilation of regulatory submission packages, operational briefs, performance summaries, and periodic reports for internal and external stakeholders
• Improve and oversee documentation flow, version control, filing systems, and SOP adherence across departments, identifying gaps or bottlenecks and proposing solutions to streamline processes
• Proactively flag risks, potential delays, or pending actions to the Site Manager and relevant study teams, issuing timely reminders and follow-ups to department heads, study coordinators, and administrative staff
• Identify process inefficiencies, propose and implement solutions, and ensure tasks move from planning to completion, supporting accountability and operational excellence across the site

Vacancy Requirements:

• Bachelor’s Degree in Public Health, Business Administration, Project Management, Health Systems Management, or related field
• Minimum 1–2 years’ experience in: Clinical research administration, Project coordination, or Executive/operations support in a fast-paced environment
• Experience working in clinical trials or research environments is an added advantage – Added Advantage
• Familiarity with IRB/EC and regulatory submission processes
• Knowledge of using project management tools
• Strong stakeholder engagement and follow-up skills
• Strategic thinking ability beyond pure administration
• Strong organizational and prioritization skills
• High attention to detail, especially in regulatory tracking
• Ability to manage multiple parallel workstreams
• Proactive problem-solving mindset
• Strong written and verbal communication skills