München (81249), Bayern
about 1 year ago
·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.