Vacancy Regulatory Affairs Officer – Brussel
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 company is a Belgian pharmaceutical agglomerate with focus on the distribution of medicines and the development and manufacturing of generic pharmaceutical products for worldwide markets. In total there are over 125 employees and counting. The group distributes a wide range of pharmaceutical products to pharmacies, wholesalers and hospitals. At the same time, this 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 Regulatory Affairs Officer you have various tasks/responsibilities. One of your main responsibilities is to provide assistance in preparing and submitting license requests and variations to the EMA/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 filling out the draft license requests.
The ideal candidate has the following requirements:
- Life science related Master degree, such as Biomedical Sciences, Pharmaceutical Sciences or related
- 1-3 years of working experience
- Strong administrative skills
- Good knowledge of MS Office
- Interest in the pharmaceutical world, knowledge and/or experience is a big plus
- Strong interpersonal skills, such as eye for detail and big amount of commence
- Good command of both French, Dutch and English
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!
- Annual salary between €36,000 and €39,000 including holiday allowance and 13th month
- Hospitalisation and group insurance
- Excellent career progression opportunities, both in seniority and nation wide
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Martin van der Velden
Principal Associate | Biotech & Pharma