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Study Start Up & Regulatory Director

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  • Study Start Up & Regulatory Director
    Job type: Permanent
    Location: Munich or the Cologne Area (with up to 2 days home working)
    Salary: Flexible for the right candidate
    Reference Number: J23349

    Want to have oversight over the Study Start Up department in a world leading CRO?
    Looking to have the flexibility to work from home partially?
    Want to have strong input into global regulatory strategy?

    My client is a full- service clinical research organisation, providing the full range of Phase I-IV clinical development services for the world's pharmaceutical, biotech and medical device industries. This organisation has business that spans across six continents, and are looking to strengthen their Ethics and regulatory department in the UK.

    Job Description:
    As a leading member of the Study Start Up team you will cover a wide variety of therapeutic areas and phases.
    - Line managing a team of 10-15 staff at various levels
    - Develop and implement comprehensive global strategy
    - Leading projects regarding clinical trial submissions to CA, LEC and CEC
    - Lead Business development activities including bid defences
    - Have oversight and significant input into major SSU projects

    Job Requirements:
    - Must speak fluent German
    - 10+ years"e; experience in Regulatory Affairs
    - Strong line Management experience
    - Leadership experience
    - Ethics Committee submission experience in multiple countries
    - Global submissions experience

    Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.
    Key words: Regulatory, Regulatory Affairs, SSU, Study Start Up, Director, Regulatory Affairs Director Clinical, CTA, Ethics Committee, Germany, Munich, Cologne, Dusseldorf, home working, Competent Authorities, Site Activation


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