• 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.

     

    Please click here to view the benefits package offered to those on the CRF Health Payroll. 

     

    CRF Health aspires to be the market leading provider of patient centred eSource technology and service solutions focused on flexibility and innovation, underpinned by deep regulatory and technical knowledge and high-quality service delivery.

     

    We have offices in Finland, Romania, the US and the UK and continue to grow in terms of revenues, customer numbers and employees.

     

    CRF Health creates electronic Clinical Outcome Assessment (eCOA) solutions that are simple, scalable, and effective. From our collaborative, agile design approach to our user-friendly reporting tools, we streamline complex processes and deliver reliable results for superior clinical trial outcomes. We improve patient engagement with intuitive design, support study teams with tailored scientific insights, and secure high-quality data with precision. Above all, we ease the path to approval.

     

    Our personalized service and unparalleled eCOA expertise helps sponsors bring new medicine to market quickly and cost-effectively, improving lives across the world.

     

    Our UK operations are in Hammersmith, London and Sandwich, Kent. Please note that we will be relocating our Hammersmith offices in September 2018 to 12 minutes walk from our current location to Waterfront, Manbre Road, Hammersmith, London W6 9RH

     

    We are an equal opportunities employer. All positions at CRF Health are offered subject to certain conditions which will include your right to work in the United Kingdom, satisfactory references and you not having any criminal convictions (excluding spent convictions) which we consider relevant to your employment.

     

    CRF Health take GDPR very seriously and your privacy and information is important to us. Although we would like to retain your details on file, so we can understand the history of your interaction and your interest in CRF Health and our opportunities, we also want to be able to consider you for other opportunities as they arise, in coming months and years, we recognise that you may wish to remove some personal information or even have your details deleted from our portal. Should you wish to amend your details, please go in to your personal dashboard (where you were taken when signing in) and make whatever changes, additions or deletions you want, or if you wish to remove entirely, then in the dashboard against your iCIMS account click the "GDPR" button and send in the request. We routinely purge the system.

     

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