Hobson Prior are looking for a Head of Clinical and Regulatory Affairs to join a global health non-profit organisation to be either located in either Europe (Geneva or UK) or Africa (Cape Town or Nairobi) on a permanent basis. Our client is focused on growing and accelerating access to new diagnostic technologies, and to build global capacity for diagnostic testing for poverty-related diseases in low- and middle-income countries
- Accountable for the oversight, management and coordination of the organisation’s clinical activities, while ensuring compliance with regulations.
- Protocol, SOP and template development for the different studies run by the organisation.
- Guidance and assistance to disease teams and trial managers with all aspects of trial design, conduct and close-out.
- You will ensure that all clinical activities meet acceptable quality standards for diagnostic tests and that Human Subject Research is conducted in conformance to ICH GCP E6 R2 guidelines.
- Provide regulatory expertise and ensure that there is capacity within the programme to provide strategic regulatory support for products in the company’s portfolio.
- Develop new strategic approaches for regional / country-specific submissions for regulatory clearance to achieve smoother and faster country adoption pathways.
- Responsible for risk management and for reporting against Key Performance Indicators for the programme.
- Host external GCP or regulatory audits ensure any findings are addressed in a timely manner, as well as those from internal audits that apply to the programme.
- Responsible to ensure that the programme prepares for and accommodates internal audit schedules and is prepared for annual external ISO audits.
- Excellent communications and interpersonal skills, and ability to work in team environment.
- Ability to manage multiple projects and deliver results on time.
- Advanced degree in Health or Life Sciences, or equivalent.
- A minimum of 8 + years of experience in a similar role in or supporting the in-vitro diagnostics (IVD) industry.
- Experience with electronic data capture and eTMF/eQMS systems.
- Experience overseeing and conducting clinical studies (preferably in in LMICs) to include protocol design/development, site feasibility assessments, eCRF design, project management, reference testing, monitoring and report writing.
- Knowledge of IVDR (or at least an up-to-date understanding of the new regulations), FDA, and other SRA regulatory pathways, LMIC regulatory knowledge is a plus.
- Experience in quality management in clinical studies.
- Fluent in English (French/Spanish are a plus).
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.