|Publication date:||January 06 2020|
For this state-of-the-art pharmaceutical company with offices in Belgium, Ireland and the UK we are looking for a Regulatory Affairs Officer. This be-loving company is a Belgian pharmaceutical agglomerate with focus on the distribution of medicines and the development and manufacturing of generic pharmaceutical products destined for markets worldwide. In total there are over 125 employees and counting. The group distributes a wide range of pharmaceutical products to pharmacies, wholesalers, hospitals and retirement homes. At the same time, this auspicious company is a global player on the generics market, with around 15 molecules on the European and US market and a fully stocked pipeline with niche, complex and added value products.
As the Regulatory Affairs Officer you will be responsible for various tasks. One of your main responsibilities is to provide assistance in preparing and submitting license request and variations to the FDA. This will be done by looking up info about the imported and reference medicinal product, such as the composition and description, indications, marketing authorisation holder and manufacturing related info. In addition, you will complete the annexes with info about the imported medicinal product, taking the specific wording of the reference product into account and gather additional required files for the submission, such as translations. Some administrative tasks also fall under your responsibilities, such as updating the RA database and file out the draft license request.
The ideal candidate has the following requirements:
Besides a competitive salary and secondary package the organisation offers good options for career progression (senior level, management level) and the opportunity to travel all over Europe and abroad!
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Senior Associate | Biotech & Pharma