Senior Regulatory Affairs Associate
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Brabant Flamand Belgium.
The company is specialized in the development and production of veterinary medicines and is represented in more than 100 countries.
ROLE DESCRIPTION
As Senior Regulatory Affairs Associate your main task is the implementation of regulatory strategies for products in the EMEA region. Next to that you will obtain and maintain marketing authorizations for these products.
RESPONSIBILITIES
- registration, variations and renewals of your product portfolio within EMEA
- prepare and submit regulatory dossiers according EU regulatory requirements
- provide input for the correct labeling
- strong collaboration with other departments to improve processes and solve regulatory related questions
- contribute to the development of new medicines
- liaise with different regulatory authorities to discuss scientific topics
- participate in projects and give advice on the regulatory requirements/ strategies
REQUIREMENTS
- Bachelor or Master degree in Pharmacy, Life sciences or Biology/ Chemistry, PhD is a plus
- 2+ years experience within Regulatory Affairs at national or European level
- Good communication skills in English (written and spoken)
- Profound understanding of MS Office, databases and online research
- Team player, enthusiastic, able to multi-task, punctual and accurate
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Anja Paetel.
