Clinical Trials Assistant/Regulatory Submissions Coordinator - Czech Republic
1 day left
- Experience Level
- Experienced (non-manager)
Upsilon Global have partnered with mid-size global CRO with offices in 40 countries worldwide with approx. 4,000 employees. They are looking to fill an enthusiastic and passionate Regulatory Submissions Coordinator to their expanding company. They focus on quality studies on many therapeutic areas but primarily on Drug studies and Medical Devices, with the opportunity for career development and opportunities in many departments. 90% of their clients are small to medium-sized biopharma companies and have their own lab in France, Belgium, and the US!
They have been operating for 29 years as a CRO with long term stability for the employees. Even through Covid-19, they are still hiring! After 1 year of employment, you will get the opportunity to have a bit more flexibility to work a mixture of office and home based.
- Prepare, review, and file clinical trial applications to country agencies;
- Provide insightful input on regulatory submissions documents and timelines;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise on changing country regulations and compliance requirements; and
- Track submissions and ensure timely filing of documents.
- A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);
- Some experience as a Regulatory Submissions Coordinator is preferred;
- Excellent organization and communication skills;
- Fluency in English;
- Strong attention to detail;
- Knowledge of Microsoft® Office; and
- Hands-on experience preparing, reviewing, and submitting regulatory documentation is desirable.
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