Regulatory Affairs Specialist Consultant – BELGIUM

Description

As a Regulatory Affairs Specialist, you carry out all activities related to the registration of new drugs and their access to the market in compliance with the regulations. Depending on the projects, you propose, implement and ensure the implementation of regulatory strategy.

• Your work closely with Quality and Regulatory departments to maintain effective progression in line with objectives
• You inform management in case of any regulatory or quality issue
• You compile registration applications with high quality and appropriate information
• You ensure submissions to Health Authorities and that registration applications are approved by the relevant authorities.
• You maintain registrations in compliance with the procedures in place and with regulatory regulations.
• You provide regulatory guidance as needed
• You are the direct contact with customer’s and regulatory authorities regarding clinical trial and marketing applications/authorizations.

Profile

• Industrial Pharmacist or Master in Sciences with minimum 5 year experience in RA fields
• High organizational skills, good interpersonal skills, flexibility in tasks and schedules
• Sense of responsibility, enthusiasm, diplomacy and team spirit
• Fluency in French and English is mandatory (spoken and written English)

Offer

• An attractive and competitive salary with fringe benefits
• A challenging & innovative environment with space for individual initiative & personal growth
• Training opportunities if needed

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