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Study Start Up - Regulatory Submissions Coordinator

Study Start Up - Regulatory Submissions Coordinator

  • Location

    München (81249), Bayern

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    benefits package

  • Contact:

    Denise Saab

  • Contact email:

    Denise.Saab@volt.eu.com

  • Job ref:

    74008-PHARM-DEB_1561642123

  • Published:

    4 months ago

  • Expiry date:

    2019-07-27

  • Start date:

    May

  • Consultant:

    #

Responsibilities:
·Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Germany, Austria and Switzerland;
·Prepare and submit responses to queries and amendments to clinical trial applications;
·Ensure submissions comply with applicable regulations and guidance documents;
·Advise sponsors on changing regulations and compliance requirements;
·Track submissions and ensure timely filing of documents;
·Collection of essential documents and preparation essential documents packages for drug release.
Clinical Operations role

Qualifications:
·Bachelor's degree in life sciences;
·Excellent organisation and communication skills;
·Knowledge of Microsoft® Office;
·Hands-on experience preparing, reviewing, and submitting regulatory documentation;
·At least one year of work experience as a Regulatory Submissions Coordinator;
·Fluency in English and German language.