• Head of Regulatory Affairs

    Job Locations UK-Hammersmith, London, UK
    Job ID
    2018-2880
    Category
    Regulatory
    Position Type
    Permanent Employee - Full-Time
  • Position Summary

    Head of Regulatory Affairs - Hammersmith, UK base

     

    This position leads the Group’s regulatory affairs function.  The role is to ensure that the company follows all applicable global regulations in an efficient manner consistent with the company business model.

     

    CRF Health develops software used for Clinical Trials with two main tools, eCOA and TrialConsent. Ours is a rightly a highly regulated sector and we work with various regulatory authorities including MHRA and FDA. Our clients are Pharmaceutical companies and CRO's who use our suite of products as part of the Clinical Trials of new drugs and therapies. As a company we have grown from just 420 people in March 2016 to over 620 people today. We have operations in the UK, the US, Finland and Romania and a global client base.

    Responsibilities

    • Represents the company’s regulatory position to all staff, customers, and regulatory agencies.
    • Assists project teams with regulatory issues.
    • Maintains the regulatory compliance statement provided to all customers.
    • Consults with management team to ensure that company direction is in keeping with global regulatory expectations.
    • Goals are to ensure all project teams project a consistent regulatory position and approach to all stakeholders.
    • Actively participate in clinical organizations on committees and presentations at conferences
    • Other responsibilities will be assigned as required.

    Requirements

    • Minimum education: BSc in technical or medical science
    • Minimum of 10 years in pharmaceutical clinical arena,
    • Knowledge of medical device regulation beneficial.
    • Minimum of 6+ years internal or external Software Auditor or auditee audit experience.
    • Must have excellent interaction, writing, speaking skills.
    • Must have solid MS Tool experience – Word, Excel, Visio, MS Project, PowerPoint etc.
    • Must be able to communicate effectively with staff, customers, regulatory Authorities, and Peers from other institutions.
    • Must be a team oriented person with a “can do” attitude.
    • Possess thorough knowledge of GCP and regulations like FDA, EU Directives, ICH - expert with applicable regulations, for example 21 CFR § 11.
    • Certification as an ISO quality system lead auditor.  Certification to pharmaceutical software lead auditor a plus.
    • Focus on problem solving
    • Knowledge of root cause analysis techniques
    • Knowledge of ISO software quality standards, principles & methodologies ISO 9001, ISO 12207, ISO 27002,
    • Ability to work independently.
    • Ability to consult and guide teams tasked with delivering validated systems to the clients
    • Significant experience with enterprise software and the entire product lifecycle, from inception through delivery, maintenance and end-of-life.

     

    About CRF Health

    Global Leader in eCOA Solutions

     

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    CRF Health is a global leader in eCOA (electronic Clinical Outcome Assessments) solutions for the life sciences industry. eCOA encompasses PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes) and ClinROs (Clinician or Rater Reported Outcomes) with outstanding project management focused on delivering value for our customers.  Committed to driving the change to higher quality outcomes and more efficient paper-free clinical trials through improved patient engagement, our intuitive and patient-focused eCOA technology helps companies bring new medicines to market quickly, safely and more cost-effectively. Our complete eCOA solutions are ideal for home and site-based phase I-IV clinical trials across the world for many therapeutic areas and patient populations.  More information can be found on our website.  

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