Summary
Date Posted: Tuesday, April 12, 2022 , Base Salary: Not Disclosed

JOB DETAILS:
Strategy and Policy Expert - Healthcare & Pharmaceutical Regulation (m/f/x) - Rwanda
Enabel is the Belgian development agency. It implements Belgium’s governmental cooperation. The agency also works for other national and international donors. With its partners in Belgium and abroad, Enabel offers solutions to address pressing global challenges - Climate Change, Urbanisation, Human Mobility, Peace and Security, Economic and Social Inequality - and to promote Global Citizenship. With 2,000 staff, Enabel manages about 170 projects in twenty countries, in Belgium, Africa and the Middle East. enabel.be

Background
Enabel is currently implementing a five-year cooperation program (2019 - 2024), with a total budget of 120 million euros, in four priority development sectors in Rwanda: health, agriculture, urbanization and public financial management.
Local manufacturing of vaccines is a topic which is creating a lot of interest from a vast and diverse combination of stakeholders. Firstly, the private sector has taken the spotlight recently with the announcement of BioNTech to establish a manufacturing plant of the mRNA SARS-Cov-2 vaccine or at least for part of the production process up to the stage of "Fill and Finish". Secondly, major investment development agencies, such as the European Investment Bank (EIB) or the International Finance Corporation (IFC) which is part of the World Bank group. There are also discussions and consultations being held the African level with the African Union of the African CDC (Centres of Disease Control and Prevention). Finally, at country level, traditional development partners have answered the government call. For the health sector, Enabel, as the only agency of a EU member state focusing on the health sector, has established a close relationship with the Rwanda FDA (Rwanda Food and Drugs Authority).

One critical piece required to establish local production of vaccines and other pharmaceutical products in the country is the existence of a strong regulatory agency, which is certified according to World Health Organization (WHO) Global Benchmarking Tool and needs to reach at least Maturity Level 3. Team Europe, led by the European Delegation in Rwanda and supported by Enabel has been allocated this workstream and is working closely with the Rwanda FDA to identify the gaps as well as establish a roadmap to reach the required level. In addition to direct Rwanda FDA support, this initiative has also identified key capacity gaps in the vaccine manufacturing chain and will work with the University of Rwanda (UR) to detail out a package of support for the program of Master in Biotehnology.
In order to coordinate the expected results of this program, we will recruit a Project Manager, based in Kigali.

Job description
As Strategy Expert directly reporting to the Resident Representative, you will work in close collaboration with the Rwanda FDA Director General and the management team.

Responsibilities:
You will be the project leader and responsible for the effective implementation of the activities.
• You contribute to the technical dialogue around the strengthening of pharmaceutical regulatory framework and institution to contribute to the quality of medicines, vaccines and health products in Rwanda.
• You contribute to Team Europe Initiatives in the pharmaceutical regulation and the ecosystem for production of vaccines, medicines and health technologies in Rwanda and in Africa.
• You contribute to the reflection around vaccines and health products manufacturing.
• You interact with the various stakeholders such as the Rwanda Ministry of Health (MoH), the Rwanda Biomedical Centre (RBC), the Rwanda FDA, the University of Rwanda and the development partners;
• You provide specific technical expertise in product dossier evaluation for market authorization;
• You ensure knowledge building and knowledge management in order to develop actor capacities and promote the growth of Enabel.

Your profile
Required qualifications
• Master’s degree in Pharmacy or related fields;
• A PhD in the fields relating to regulatory affairs for pharmaceuticals is an asset.

Required experience
• At least 10 years of relevant experience working in pharmaceutical regulatory affairs in at least one of the following regulatory functions – product dossier review and registration of which at least 5 years in policy dialogue;
• At least 5 years of international experience;
• Proven experience in research, and publication records in product safety;
• Proven experience with giving presentations at seminars and international conferences;
• Direct experience with products assessment procedures and of WHO global benchmarking tool and/or progression of regulatory authorities towards achieving maturity levels 3 and 4;
• Experience in Rwanda of assignment is an asset.
• Required skills and knowledge
• Good knowledge and understanding of clinical trials;
• Individual, organisational and institutional capacity development skills;
• Article-writing skills;
• Ability to use new health technologies;
• You are result oriented with good interpersonal and communication skills;
• Knowledge management and knowledge building;
• Knowledge of Theory of Change and other tools to address complexity;
• Considering the working language of Rwanda and the international environment in which you work, excellent knowledge of English is required. Being fluent in spoken and written French or Dutch is an asset.

Applicants are also required to commit to the vision, mission and values of Enabel (https://www.enabel.be/content /enabel-vision-mission-values ).

We offer you
A fascinating job in an international environment.
• A contract of 48 months. You are based in Kigali with regular field missions.
• A salary package that comprises the monthly gross salary, in accordance with our salary scales (Class 7), and Enabel expat benefits such as a remoteness, assignment and hardship allowance, (capped) coverage of housing expenses, a moving compensation, an installation compensation, (capped) coverage of school expenses for children accompanying, an insurance package for the whole family, including repatriation insurance, and an annual round-trip flight ticket for each family member.
• In case of expatriation without the (dependent) members of the family, up to six additional round-trip flight tickets to the country of origin or another destination (capped in accordance with Enabel rules).

The various amounts vary in function of relevant recognised experience for the function and family composition.
Following this recruitment procedure a shortlist of successful applicants may be constituted which may be sourced in the next three years for similar job openings.

Every person who fulfils the conditions listed in our job advertisements may apply. Enabel is committed to equal opportunities and diversity in its workforce. We do not discriminate on the basis of gender, origin, age, religion, sexual orientation, disability status or any other factor other than competence.

Job Experience: No Requirements

Work Hours: 8

Level of Education: Bachelor Degree

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