Regulatory Submissions Coordinator- officebased Belgium

Upsilon Global are working with a global CRO who are headquartered in the US and have 3,000 + employees in over 30 countries globally. As a full service CRO they work in various therapeutic areas that include oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective in all Phases I-IV working in partnership with pharmaceutical and biotechs.

The CRO has over 25 years of experience working in the clinical research field and pride themselves to have been awarded 1st Place in the CRO quality award and CRO awards in leadership.

They offer great opportunities for career growth and continuous development.

Responsibilities:

• Prepare, review, and file clinical trial applications to domestic and international regulatory agencies;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise sponsors on changing regulations and compliance requirements; and
• Track submissions and ensure timely filing of documents.

Qualifications:

• Minimum Bachelor's degree in life sciences;
• At least one year of work experience as a Regulatory Submissions Coordinator for EC/RA applications in Belgium;
• Excellent organization and communication skills;
• Knowledge of Microsoft® Office; 
• Hands-on experience preparing, reviewing, and submitting regulatory documentation; and
• Dutch or French mother tongue and very good knowledge of English.