Regulatory Affairs / Regulatory ***CONTRACT*** CTA Project Manager - Brussels

Reference: TM10505

Expiry Date: 29-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Belgium

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Job Description

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.

Required qualifications

  • 3-7+ years pharmaceutical experience with knowledge of regional regulatory procedures and legislation. Essential to have past CTA experience.
  • Build effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas.
  • Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person.  Works effectively in ambiguous situations.

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To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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