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Pharmaceutical Regulations Expert

SOFRECO

Somalie
Ingénierie, Recherche et Développement
Pharmaceutical Regulations Expert, Somalie

DESCRIPTION DU POSTE
Contrat : Court-terme
Date limite de candidature : 15/03/2021
Lieu : Somalie
Projet : SOMALIA HEALTH REGULATORY LANDSCAPE ASSESSMENT
Conseil Santé was invited to present a tender to implement a World Bank-funded project in Somalia.

Alerted by the relative weakness of health sector regulations in the Somali context, the Government, through the Federal Ministry of Health (FMoH), is seeking technical assistance to carry out the Somalia Health Regulatory Landscape Assessment. In the future, this will result in strengthening the capacities within the government including on policy, legal and regulatory reforms.

To this end, Conseil Santé is looking for an expert capable of implementing one of the essential components of the project, namely the Somalia Pharmaceutical Regulatory Landscape Assessment. The expert, working in a close-knit multidisciplinary team, will support the National Medicines Regulatory Authority (NMRA), focusing primarily on market authorization and post market surveillance.

She/he will bring his expertise to carry out, among other things, the following activities :

 • Document current practices for inspection registration & licensing of pharmaceutical products and medical devices in the country, in order to provide a landscape report to the NMRA;
 • Review the existing stakeholders and institutions related to pharmaceutical and medical devices regulations to elaborate an Institutional Development Plan for the NMRA;
 • Conduct detailed assessment and examination of the institutional arrangements for the NMRA, including analysis of its strengths and weaknesses, in order ri provide recommendations for its improvement;
 • Design functional assignment articulating roles of different levels of Government (related to pharmaceutical and medical devices regulations) integrating recommendations on how to eliminate duplication and enhance information sharing.
A qualified expert is expected to participate in this important project for the health landscape in Somalia, lasting up to four months.

QUALIFICATION
The following criteria are required for this position:

 • min. 10 years of experience supporting health regulations and in pharmaceutical and medical devices management;
 • relevant references of supporting health regulatory reforms in developing countries (preferably in Somalia or in the region);
 • relevant experiences related to pharmaceutical and medical devices regulations and regulatory reforms: regulatory impact assessment, development in inspection design;
 • the expert is ideally a Medical Doctor, a Nurse Practitioner or a Pharmacist, and has substantial public health experience;
 • experience in development of pharmaceutical regulations including development of guidelines for Medical and Pharmacy Pratice, Practice by the Allied health Professionals;
 • experience in medicine regulation including registration, GMP, notification, etc.;
 • fluent in English with excellent report writing and diplomatic skills.

REPONDRE A CETTE ANNONCE / APPLY FOR THIS JOB
Référence SOFRECO : 0S1812-LPT

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SOFRECO - 92/98 boulevard Victor Hugo, 92115 Clichy-cedex France
fax: +33 (0)1 41 27 95 96 - Email : rh@sofreco.com
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