International Consultant for Regulatory Capacity Strengthening

Job Posting Organization:
The Afghanistan Food and Drug Authority (AFDA) serves as the national regulatory authority responsible for ensuring the quality, safety, and efficacy of medicines, medical devices, healthcare products, and food in Afghanistan. Established to protect public health, AFDA is tasked with implementing regulatory reforms in alignment with WHO norms and standards. The organization is focused on enhancing its regulatory capacity to address challenges such as limited technical expertise and the need for improved adherence to quality standards. AFDA aims to strengthen its regulatory functions through the implementation of the WHO Global Benchmarking Tool (GBT), which provides a structured framework for assessing regulatory maturity and developing Institutional Development Plans (IDPs).

Job Overview:
The consultancy aims to enhance the regulatory capacity of the Afghanistan Food and Drug Authority (AFDA) specifically in the area of product registration. The consultant will focus on improving dossier evaluation processes, assessing the feasibility of implementing the Common Technical Document (CTD) system, and developing a roadmap for its adoption. Additionally, the consultant will support the development of technical capacity among registration staff and contribute to the effective implementation of WHO Global Benchmarking Tool (GBT) Institutional Development Plans (IDPs). The ultimate goal is to strengthen AFDA’s ability to efficiently register medicines and healthcare products, thereby safeguarding public health in Afghanistan. This role requires a comprehensive understanding of pharmaceutical regulation and the ability to provide targeted expertise and hands-on mentoring to AFDA staff.

Duties and Responsibilities:
The consultant will be responsible for several key outputs: 1) Conducting an assessment of current product registration and dossier evaluation processes, culminating in a detailed report that includes a gap analysis and recommendations for upgrading to the CTD system. 2) Developing a roadmap document that outlines the process, timeline, and milestones for transitioning to the CTD. 3) Preparing updated regulatory guidelines and standard operating procedures (SOPs) to enhance the registration process. 4) Conducting comprehensive training for AFDA staff, with a detailed report documenting the implementation, participation, content, and outcomes of the training activities. The consultant will work under the supervision of designated WHO officials and will be expected to provide regular updates on progress and challenges encountered during the consultancy.

Required Qualifications:
Essential qualifications include a university degree in Pharmacy, with a specialization or Master’s degree in regulatory affairs or pharmacy being desirable. Candidates must possess excellent interpersonal and communication skills, a high sense of responsibility, and strong organizational abilities. Advanced computer literacy in applications such as Word, Excel, and PowerPoint is also required. The consultant must demonstrate a commitment to ethical standards and professional integrity, as well as the ability to work effectively under pressure.

Educational Background:
Candidates must hold a university degree in Pharmacy as a minimum requirement. A specialization or Master’s degree in regulatory affairs or a related field is preferred, indicating a deeper understanding of the regulatory landscape and practices.

Experience:
The position requires 5 to 10 years of relevant experience in pharmaceutical regulation and product registration. International experience is mandatory, as it provides the necessary perspective and expertise to navigate the complexities of regulatory systems in a global context. Candidates should have a proven track record of working with regulatory authorities and implementing capacity-building initiatives.

Languages:
Fluency in English is mandatory, as the consultant will be required to communicate effectively with various stakeholders and produce documentation in English. Knowledge of additional languages may be considered an asset but is not explicitly required for this position.

Additional Notes:
The consultancy is expected to run from July 1, 2026, to September 30, 202

• The selected consultant will be required to provide a medical certificate of fitness for work and will be responsible for fulfilling visa requirements for travel to Afghanistan. All travel arrangements will be managed by WHO, and the consultant will receive a subsistence allowance during missions. The position is classified as a consultancy, and the consultant will operate as an independent contractor, not as a representative of any entity. WHO emphasizes a commitment to diversity and inclusion in its workforce and encourages applications from women, persons with disabilities, and nationals of underrepresented Member States.