The Office of the Director General provides strategic leadership, executive management, and oversight of Rwanda FDA and is responsible for:

1. Providing the legal representation of Rwanda FDA and serving as the principal liaison with Government institutions, stakeholders, partners, and the public;

2. Overseeing and coordinating the day-to-day operations and performance of Rwanda FDA to ensure the effective implementation of its mandate;

3. Ensuring the implementation of decisions and directives of the Board of Directors;

4. Providing leadership and oversight for the management of human resources, assets, infrastructure, equipment, and other resources of Rwanda FDA;

5. Coordinating the preparation and submission of strategic plans, annual action plans, budgets, performance reports, and other institutional reports for consideration by the Board of Directors and relevant authorities;

6. Coordinating the development, implementation, monitoring, and continual improvement of institutional policies, internal rules and regulations, and management systems;

7. Providing oversight for the implementation, monitoring, and evaluation of Rwanda FDA’s strategic objectives, operational plans, and organizational performance;

8. Promoting effective governance, accountability, risk management, quality management, and compliance with applicable laws, regulations, policies, and standards.

These roles and responsibilities are implemented through the following functions and divisions:

1. Legal Affairs

2. Public Relations and Communications

3. Internal Audit 

4. Quality Management System Division

   Legal Affairs

  The Legal Affairs function is responsible for:

1. Providing legal advice and opinions to the Board of Directors, the Office of the Director General, departments, divisions, and units on matters relating to the mandate, operations, and regulatory functions of Rwanda FDA;

2. Supporting the development, review, interpretation, and implementation of laws, regulations, policies, and internal governance instruments relevant to Rwanda FDA;

3. Representing Rwanda FDA in courts of law, tribunals, arbitration proceedings, and other dispute resolution mechanisms;

4. Managing litigation and legal disputes involving Rwanda FDA, including the review and response to legal notices, claims, complaints, and notices of intention to institute legal proceedings;

5. Liaising with national, regional, and international institutions on legal, regulatory, insurance, and other matters of legal interest to Rwanda FDA;

6. Coordinating investigations and enforcement actions relating to contraventions of applicable laws, regulations, and regulatory requirements within the mandate of Rwanda FDA;

   Public Relations and Communications

  The Public Relations and Communications function is responsible for:

1. Developing, reviewing, and disseminating communication content and materials through appropriate communication channels, including the Rwanda FDA website, social media platforms, publications, awareness campaigns, and other internal and external communication platforms;

2. Managing media relations and public communications, including maintaining media databases, preparing press releases, public notices, speeches, and coordinating media engagements, press conferences, and public awareness activities;

3. Providing accurate, up-to-date, and authorized information to the public and stakeholders on matters relating to Rwanda FDA in accordance with established communication procedures;

4. Supporting stakeholder engagement through stakeholder mapping, communication planning, feedback mechanisms, and targeted communication initiatives;

5. Monitoring media, social media, and other information sources to identify, analyze, and report issues, trends, and public concerns relevant to Rwanda FDA and its mandate.

   Internal Audit 

 The Internal Audit Office is responsible for:

1. Providing independent and objective assurance to the Board of Directors, through the Audit Committee, on the adequacy and effectiveness of governance, risk management, internal control, and compliance systems within Rwanda FDA;

2. Developing and implementing risk-based internal audit plans and conducting financial, operational, compliance, and performance audits in accordance with approved audit programs and professional standards;

3. Assessing compliance with applicable legal, regulatory, policy, and procedural requirements, as well as the adequacy and effectiveness of internal controls, and recommending measures to enhance governance, accountability, operational performance, and risk management.

4. Conducting special audits, investigations, and reviews as requested by the Board of Directors, the Audit Committee, or other competent authorities, and reporting findings and recommendations accordingly.

5. Preparing and submitting audit reports, follow-up reports, and periodic updates on the implementation of audit recommendations to the Audit Committee and the Board of Directors.

   Quality Management System Division

The Quality Management System (QMS) Division is responsible for:

1. Establishing, implementing, maintaining, and continually improving Rwanda FDA’s Quality Management System in accordance with applicable ISO standards, WHO Global Benchmarking Tool requirements, and national regulatory obligations. 

2. Coordinating the integration, implementation, monitoring, and evaluation of QMS processes across Rwanda FDA to promote consistency, effectiveness, efficiency, and compliance;

3. Coordinating internal and external audits, management reviews, organizational assessments, and quality improvement initiatives, and monitoring the implementation of corrective and preventive actions;

4. Managing document and records control systems and promoting a culture of quality, risk-based thinking, continual improvement, and evidence-based decision-making throughout Rwanda FDA;

5. Monitoring organizational performance, customer satisfaction, and stakeholder feedback, and providing recommendations to enhance institutional effectiveness and service delivery; and

6. Supporting the promotion of conducive working environment organizational capacity development, and collaboration with relevant functions to strengthen regulatory performance, stakeholder confidence, and the achievement of Rwanda FDA’s strategic and quality objectives.