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Regulatory Affairs Officer

28.11.2018 REF: O180133 Flemish-Brabant

Organization

CRO

Description of the Position

Responsibilities:
• Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications
• Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
• Review translations of essential documents subject to clinical trial submission
• Track the regulatory project documentation flow
• Review documents to greenlight IP release to sites
• Manage safety reporting to authorities
• Deliver regulatory training to project teams
• Assist with feasibility research and business development requests

Demands of the Position

• College/University degree in Medicine or life sciences, or an equivalent combination of education, training and experience
• Prior experience with clinical trial submissions in Belgium
• Full working proficiency in Dutch, English and French
• Proficiency in MS Office applications
• Detail-oriented
• Ability to learn, plan and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills

Terms of Employment

Directly at the clients headcount.
Interested in this challenge?! For more information, feel free to contact Nick Dufour at 0032 (0)475 87 02 36 or n.dufour@theclinicalcompany.com or apply directly.

Nick for Belgium

Didn’t find the right job on our website yet? Interested in an introduction of our company and what we can do to your career? Please feel free to contact me!

+32 475 87 02 36n.dufour@theclinicalcompany.com

Stijn for the Netherlands

Didn’t find the right job on our website yet? Interested in an introduction of our company and what we can do to your career? Please feel free to contact me!

+316 5364 1197s.valkering@theclinicalcompany.com

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