Study Start Up - Regulatory Submissions Coordinator

  • Location

    München (81249), Bayern

  • Sector:

    Life Sciences

  • Job type:


  • Salary:

    benefits package

  • Contact:

    Denise Saab

  • Contact email:

  • Job ref:


  • Published:

    about 1 year ago

  • Expiry date:


  • Start date:


·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

·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.