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Head of Clinical and Regulatory Affairs

Employer
Hobson Prior
Location
Switzerland / Western Cape, South Africa, Cape Town / Kenya, Nairobi
Salary
£116604.60 - £133262.40 per annum
Start date
10 Oct 2019
Closing date
7 Nov 2019

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Job Details

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

Job Responsibilities:

  • 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.

Key Skills:

  • Excellent communications and interpersonal skills, and ability to work in team environment.
  • Ability to manage multiple projects and deliver results on time.

Requirements:

  • 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).

Apply now:

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.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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