10 maanden geleden
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.
Our client European activities are growing rapidly, and we are seeking a full-time, office-based Regulatory Submissions Coordinator to join the Clinical Operations team. You will be working on a team to accomplish tasks and projects that are instrumental to the company's success.
The company culture is focus on the expertise and quality, they empower their teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting their partners.
*Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees local and international regulatory agencies;
*Ensure submissions comply with applicable regulations and guidance documents;
*Advise sponsors on changing regulations and compliance requirements;
*Prepare and submit responses to queries and amendments to clinical trial applications;
*Track submissions and ensure timely filing of documents;
*Collection of essential documents and preparation essential documents packages for drug release.
*Bachelor's degree in life sciences;
Excellent organization and communication skills;
Knowledge of Microsoft® Office;
Hands-on experience preparing, reviewing, and submitting regulatory documentation;
*At least 2 years of work experience as a Regulatory Submissions Coordinator;
Fluency in English