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REGULATORY AFFAIRS OFFICER (Pharmaceuticals)

Position overview

The Regulatory Affairs Officer is part of the Regulatory Affairs department within the organisation and assists the Regulatory Affairs Director BeNeLux in the regulatory activities related to the current and new product portfolio.

Job responsibilities

• Prepares, submits and follows-up registration dossiers for medicinal products in BeNeLux ( e.g. New drug applications, variations and renewals)

• Maintains a database for registered technical details

• Adapts & verifies SPC (Summary of Product Characteristics) PIL (Product Information Leaflet ) and packaging materials

• Implements labelling of marketed products following approval

• Provides support for pharmacovigilance activities and PSUR (Periodic Safety Update Report) submissions

• Runs follow-up and interpretation of legislation

• Develops his/her expertise in specific areas such as nutrients Profile

• Pharmacist or master degree in biomedical or life sciences Organizational Alignment

• Reports to the Regulatory Affairs Director BeNeLux

• Interacts internally with medical department

• Interacts with national Health Authorities

Required qualifications

• Fluent in Dutch with ability to interact in French & English

• High level of accuracy demanded ( eye to detail)

• Highly organised (multi-tasking) & proactive in his/her work

• Flexible and able to work under stress to meet deadlines

• Team player towards internal stakeholders (cross-functional mindset)

• Dynamic and dedicated to his/her responsibilities

• Accountability and positive mindset

• Proficient in MS Office ( Mainly WORD & EXCELL)

• Experience in a similar position is an asset

• Knowledge of the pharmaceutical industry and its environment is an asset

• Ideally located

Company offer

• A full-time job in a dynamic environment

• A salary dependant on relevant experience + competitive package and extra-legal benefits

• Training courses

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