Regulatory Submissions Coordinator

11-9-2019 heverlee
company profile

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,700 people across 36 countries.

Interested? Apply via or call 03 369 65 88 for more information.

job description

Are you a regulatory affairs specialist looking for a new challenge? Look no further!

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.

your contribution

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 organizational and communication skills;
Knowledge of Microsoft® Office; and
Hands-on experience preparing, reviewing, and submitting regulatory documentation;
Fluent in Dutch or French and English

what do we offer?

When you join Medpace, you become part of a team dedicated to supporting the development of ground breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

project manager (m/f)
employment type
full time
contract type
immediate permanent employments
your Randstad contact
Anneleen Vanbuggenhout 03 369 65 88
03 369 65 88