Regulatory Affairs Officer

In order to support its expansion, Menarini is currently looking for a Regulatory Affairs Officer.

Key Responsibilities will be the support of the regulatory activities within the Menarini Benelux organisation, 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 and PSUR submissions
• Assistance in SOP writing
• Follow-up and interpretation of legislation
• Development of expertise in specific areas such as nutrients

Profile:

• Pharmacist or University degree in biomedical sciences - authorisation as Responsible Pharmacist is an asset
• Experience in regulatory affairs is mandatory
• Knowledge of regulations for pharmaceutical products and nutrients
• Accurate and efficient
• Flexible, dynamic, organized, teamplayer
• Very good knowledge of English, French and Dutch

You will report to the Regulatory Affairs Director.

If you are interested in this position, please fill out the online application form HERE