Regulatory Affairs Officer - Pharmacist

Key Responsibilities will be the support of the regulatory activities including but not limited to:

• Preparation, submission and follow-up of registration dossiers for medicinal products in Benelux (new applications, variations and renewals)
• Maintenance of a database for registered technical details
• Adaptation and verification of SPC, PIL and packaging materials
• Implementation of labelling of marketed products following approval
• Support for pharmacovigilance activities
• Assistance in SOP writing
• Follow-up of legislation
• Development of expertise in specific areas such as nutrients

• Pharmacist or Master degree in pharmaceutical sciences
• Experience in regulatory affairs is an asset
• Knowledge of regulations for pharmaceutical products
• Accurate and efficient
• Flexible, dynamic, organized, teamplayer

•  Very good knowledge of Dutch, French and English

We offer a dynamic and challenging multicultural work environment in which competence and quality play an important role. Enhancing personal growth and a real opportunity to invest in your future through on the job development and training. Where your effort, dedication and initiative are rewarded by a competitive and comprehensive compensation and benefits package incl. company car.