Our client is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Their headquarters are located in the USA and they are active in over 45 countries across the globe. Their clinical activities are growing rapidly so they are seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team.
This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
- Prepare, review, and file clinical trial applications to domestic and international regulatory agencies
- Ensure submissions comply with applicable regulations and guidance documents
- Provide support with local site contract & budget negotiations
- Advise sponsors on changing regulations and compliance requirements
- Track submissions and ensure timely filing of documents
Education and Qualifications:
- Bachelor's degree in life sciences;
- Experience with site contract & budget negotiations preferred, but not required
- Excellent organization and communication skills;
- Knowledge of Microsoft® Office; and
- 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 local language.
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 Linda Sporleder on +44 203 0789 550 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.