Expiry Date: 29-12-2020
Category Regulatory Affairs
Job Type: Full Time
Regulatory Affairs / Regulatory ***CONTRACT*** CTA Project Manager - Brussels
Location: Central Brussels, parking is available, but the offices are close to a major train station so easily commutable.
My client is a medium sized Global Biotechnology company with 4 core therapeutic areas. They have 11 indications in development and a strong number of recently marketed products. They have been expanding year-on year for the last five years and have a number of major product launches planned over the next 3 years. They offer a friendly, positive and dynamic working environment with good levels of flexibility around home working.
In the short-term this role will be focused on managing the operational activities around a number of global clinical trials, being the link between the regional and Global Regulatory teams and the assigned CRO. In the longer term there could be scope to expand your input and support a number of other regulatory submissions/activities including Paediatric applications, scientific advice and MAA’s.
As the Regulatory CTA Project Manager you will prepare and deliver regulatory operational plans for assigned Clinical Trial projects/products within a specific region, but also provides strategic and operational regulatory input and guidance in cross-functional teams whilst liaising with the designated CRO. The Regulatory CTA Project Manager manages the CTA activities to agreed project targets and works flexibly within and across regions to provide broad operational support to ensure the delivery of the business objectives.
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