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