Regulatory Submissions Coordinator

Proclinical is working with a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. This company's European activities are growing rapidly, and we are currently seeking an office- or home-based Regulatory Submissions Coordinator to be based in Munich. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success.

Job 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.

Skills and Requirements:

• Bachelor's degree in life sciences;
• Excellent organization and communication skills;
• Experience with site contract & budget negotiations preferred, but not required;
• Knowledge of Microsoft® Office; and
• Hands-on experience preparing, reviewing, and submitting clinical trial applications;
• Fluency in English and local language.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Hanna von Schubert on +44 203 854 0201 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.