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Regulatory Affairs Junior – Antwerp

Introduction

Our client develops innovative, effective, safe and easy-to-use wound and skin healing solutions.

Organization

We are looking for a Regulatory Affairs Junior to support the Regulatory Affairs Department concerning the registration and the maintaining of all products in the countries where our client commercializes its products in order to cope with the ISO standards and other regulations.

The Regulatory Affairs Junior will advise on legal and scientific restraints and requirements which means collecting, collating and evaluating scientific data.

This full-time and permanent position will be located in Belgium or in Luxembourg.

Function

Support the Regulatory Affairs’ department in preparing product technical dossiers and other regulatory documents for registration submissions in and outside EU

Support the Regulatory Affairs’ department in keeping product technical dossiers and other regulatory documents up to date during the lifecycle of Flen’s products

Help to be compliant and to maintain the CE and ISO certificate requirements

Participate in the implementation of the new Medical Device Regulation within our client.

Support the regulatory compliance of communication activities and materials (brochure, presentation, packaging material etc.) regarding Flen’s products, in close collaboration with marketing and sales

Attend relevant courses (internal and external) to further expand current knowledge of regulatory affairs related to EU or FDA and or non-EU regulations and willing to keep your knowledge updated by self-education/ training

Keep abreast of international legislation, guidelines and customer practices by keeping in contact with official institutions

Identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated

Work in close collaboration with Regulatory Affairs team.

Requirements

Master’s degree in Industrial Pharmacy/Pharmaceutical Sciences or related scientific Master

First Professional experience in international regulatory affairs is added value .

Willing to acquire knowledge of regulatory affairs related to EU or FDA or other non-EU regulations

Ability to read and understand competent authority regulations, guidance documents, test reports and technical/chemical product information

Strong time and project management skills/knowledge is an asset

Proficient with all Microsoft Office applications (Word, Excel, Power Point, Project, etc.), experience in Data capturing tools is a plus

Self-motivated team worker

Share recommendations, experiences and best practice with colleagues

Creating enthusiasm and initiative to make things happen

Listening to others and giving constructive feedback

Fluency in English, both written and spoken, another language is an asset.

Information

Mieke Gysens +32 497 59 44 26

Application

Mieke Gysens +32 497 59 44 26

Mieke.gysens@medipartner.be