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For our operations in Johannesburg/South Africa, we are looking for an
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Senior Specialist (m/f/d) Pharmaceutical Regulation
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Field of activity
Expanding vaccine production capacity worldwide is essential for global pandemic prevention and control and equal vaccine distribution. Thus, during the COVID-19 pandemic, vaccine production on the African continent has become the top issue in global public health.The German Federal Ministry for Economic Cooperation and Development (BMZ) is committed to supporting local vaccine manufacturing in Africa. This includes engagement at global, regional and country level (e.g.South Africa, Ghana).
BACKUP Health contributes to improving framework conditions for local manufacturing in Africa. Building on the results of the African Union Local Vaccine Manufacturing Summit 2021 and acknowledging the leadership of the AU and the critical role of its institutions the program has joined the newly formed Partnership for African Vaccine Manufacturing in Africa (PAVM). It engages, among others, with the Secretariat of the Partnership at the Africa Center for Disease Control, the designated Africa Medicines Agency, the World Health Organisation, the Medicine Patent Pool, academia and the private sector.
This position will work with the African Medicines Regulatory Harmonization Initiative to enhance the regulatory environment for vaccines and medical devices in Africa and to support the transition from the initiative to the envisioned African Medicines Agency.The expert will be embedded in AUDA-NEPAD, Program Delivery and Coordination Directorate, Midrand-Johannesburg. The position is integrated in the GIZ Portfolio with the African Union based in South Africa.
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Your tasks
- Advise on all regulatory and quality control aspects of vaccine research and development, licensing and post-market surveillance
- Contribute to the work of selected technical committees, RCORE and the initiative and advise the African Medicines Regulatory Harmonization Initiative (AMRHI) and the respective unit at African Union Development Agency-NEPAD
- Advise on organizational development from the current initiative towards the designated AMA
- Contribute to reporting, presentations, articles, case studies and other documentation, Monitoring and Evaluation
- Support implementation of AUDA-NEPAD regulatory workstream for PAVM
- Support linkages and alignment with other AMRHI/AMA entities, African CDC, Regional Economic Communities, other development partners and within German development cooperation projects and initiatives
- Contribute to requests from the Federal Ministry of Economic Cooperation and Development, GIZ, internal knowledge management and to other tasks and events as requested
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Your profile
- University degree in Medicine, Pharmacy or Biology, Master in relevant area
- Certified adcanced training in Regulation of Pharmaceuticals, Control of Infectious Diseases/Vaccinology,
- Excellent knowledge of the regulatory and vaccine production environment
- Familiarity with institutions, organization, actors, processes and mechanisms in the pharmaceutical sector and with the African Public Health systems
- Several years of relevant professional experience, preferably gained abroad, in the pharmaceutical industry and on various aspects of regulation
- Ability to engage in policy dialog and negotiations for added value to enhancing framework conditions for local vaccine manufacturing
- Ability to work in a multicultural environment
- Business fluent in English; French desired (but not required)
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If we caught your interest, we are looking forward to your application until 01/09/2022.
For further information: https://jobs.giz.de/index.php?ac=jobad&id=56416
You can find the full job advertisement and further detailed information in our job market on the GIZ job and career pages at www.giz.de.