Réf.
2024/RSAEE/10641
Type d'offre
Experts
Type de contrat
Contrat de prestation de services
Date limite de candidature
29/02/2024 09:36
Durée de la mission
Court terme
Contrat
Indépendant / Entrepreneur Individuel
Durée
15 jours
REGULATORY STRENGHTENING AND EVALUATION EXPERT (H/F)
Département Santé - DEPSAN > Pôle Renforcement des systèmes de santé
Mis en ligne le : 06/02/2024
AFRIQUE SUBSAHARIENNE
RWANDA
KIGALI
Description de la mission
Duration: Minimum 12 days in Kigali – 3 days remotely to finalise the report
Sector: Strengthening the Rwanda Food and Drugs authority trough the Twinning Project
2. Description of the mission :
As REGULATORY STRENGHTENING AND EVALUATION EXPERT within the Rwanda FDA Twinning project team and under the supervision of the Resident Twinning Advisor, the objectives expected are:
1. Feasibility Assessment:
- Conduct a detailed analysis for an operational extension of the project.
- Examine financial, technical, and operational aspects.
2. Identification of Additional Needs:
- Identify areas where an extension would be beneficial.
- Assess human, financial, and technological resource requirements.
3. Stakeholder Consultation:
- Organize meetings with key stakeholders to gather information and feedback.
- Ensure active participation from current project partners.
4. Proposal of Extension Plan:
- Develop a detailed plan for the project extension.
- Include a timeline, estimated budget, and performance indicators.
5. Risk Analysis:
- Identify potential risks associated with the project extension.
- Propose mitigation strategies for each identified risk.
6. Final Report:
- Prepare a final report detailing the extension proposal.
- Include all recommendations and conclusions from the conducted analysis.
Description du projet ou contexte
Expertise France is the French public international cooperation agency. It designs and implements projects which aim to contribute to the balanced development of partner countries, in line with the Sustainable Development Goals (SDGs) of the 2030 Agenda and the priorities of France’s external action. Its mission is to support the capacity building of partner countries in the definition and implementation of public policies adapted to the needs of the population, contributing to the achievement of the Sustainable Development Goals (SDGs). Expertise France operates within the framework of public contracts, financed by French bilateral aid or through international tenders. The agency offers a wide range of interventions, based on multi-stakeholder partnerships, in areas such as economic and financial governance, social protection and employment, health, sustainable development and issues of stability, safety and security.
1. Project Description:
In an effort to support the Rwanda Food and Drugs Authority to improve its regulatory functions Related to medicinal products including vaccines, a Consortium of European countries set up a twinning Project for Rwanda. In this regard, Expertise France is coordinating the implementation of this EU Funded Twinning project aimed at strengthening the Rwanda Food and Drugs Authority (Rwanda FDA) in its regulatory functions related to medicinal products including vaccines. This twinning project involving several regulatory agencies from EU Member States aims to support the Rwanda Food and Drugs Authority to improve the enabling environment for regulation of medicinal products and vaccines in the country. To achieve this overall objective, the project has three components:
1. Improving legal framework and regulatory functions linked to medicinal products
2. Strengthening of market surveillance and control function - vigilance & laboratory testing functions
3. Support the establishment of the official batch release function for vaccines
After one year of implemntation of the Twhinning in support to the Rwanda Food and Drugs Authority, Expertise France is anticipating a no-cost extension of the projet (extention of the timeline, without extension of the budget)
Profil souhaité
- Master’s degree in Pharmaceutical Sciences, Doctor in medicine, Biochemistry and Science
- A PhD in the field relating to regulatory affairs for pharmaceuticals is an asset Required experience
- At least 10 years of relevant experience as project manager in the pharmaceutical regulatory affairs sector (ie Drug regulatory affairs, market control, market authorization, vigilance, inspection, regional and international cooperation…)
- 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 Africa would be an assed
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Required skills and knowledge
- Good knowledge of all regulatory functions
- Advanced skills in EU project planning
- Strong knowledge of the current agenda on regulatory harmonization in Africa and the support provided by the European Commission to AUDA NEPAD, WHO and EMA and the support provided by the European partners such as Expertise France, GIZ and Enabel
- Ability to work collaboratively with diverse stakeholders.
- Excellent organizational skills;
- Adaptability and flexibility with priority setting capacities;
- Excellent oral and written communication skills;
- You are fluent in spoken and written French and English
Informations complémentaires
Send a complete application (CV + Cover Letter)
Duration: Minimum 12 days in Kigali – 3 days remotely to finalise the report
Pour candidater, merci d'envoyer votre CV et Lettre de Motivation, 3 références pourront être demandées si votre candidature est pré-selectionnée.
Les candidat(e)s intéressé(e)s par cette opportunité sont invité(e)s soumettre leur dossier dans les meilleurs délais, Expertise France se réservant la possibilité de procéder à la présélection avant cette date. Sans réponse de notre part dans un délai de 3 semaines, veuillez considérer que votre candidature n’a pas été retenue
Critères de sélection des candidatures
Le processus de sélection des candidats s'opérera selon le(s) critère(s) suivant(s) :
- Formation/diplômes du candidat en lien avec la mission d’expertise
- Compétences du candidat en lien avec la mission d’expertise
