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Irfa******
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Germany
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Last Update: 03.02.2019 at 12:00
Job Type
Full Time
Start
ASAP
Duration
10 Month +
Place
Munich, DE
Country
Germany
Category
Regulatory, Quality and Clinical
Description
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.
Qualifications
Bachelor's degree in life sciences;
Excellent organization and communication skills;
Knowledge of Microsoft