Job Alert: Regulatory Expert
QUAMED (www.quamed.org) is a not-for-profit organisation specialising in various aspects of pharmaceutical quality assurance. We conduct pharmaceutical assessments and audits, develop and facilitate training courses around pharmaceutical quality, auditing and inspection and organise and provide technical assistance in the field of pharmaceutical quality assurance.
We are starting a new project in Senegal with as objective to support the national regulatory authority to obtain and maintain WHO Global Benchmarking Tool maturity level 3 and eventually 4. To assist us in that project, we are looking for a new colleague with significant experience working with or for regulatory authorities. Our new colleague should be a seasoned expert interested in contributing to improving a regulatory system sustainably.
We are looking at filling one long-term assignment with an in-country placement in Senegal. The initial contract will be for two years with possibility of extension for up to four years.
The assignment will include, but not be limited to, on-the-job training and mentoring, training facilitation, document and standard development, joint audits and inspections and many other elements that will improve the regulatory authority’s systems, processes and operations. In addition, the expert will be responsible for various elements of the project management.
We are looking for a regulatory expert with professional proficiency in both French and English and as far as possible and knowledge of :
- Product dossier evaluations, Registration & Market authorisation (including vaccines)
- Regulatory licensing and Good Manufacturing Practices Inspections (including vaccines)
- Legal framework and regulatory support
- Clinical trial oversight
- Pharmacovigilance
- Vaccine lot release
- General Quality Management System support
Expertise with WHO Listed Authorities or authorities with maturity level 3 or 4 would be highly appreciated. Good knowledge of the WHO Global Benchmarking Tool is essential. The remuneration package will be negotiated with the successful candidate.
If you fit the profile and would like to know more about the position, please do not hesitate to send an email with a motivation letter and your CV to info@quamed.org.
With best regards,