SIRE 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 companyOur client is a professional Biotechnology and Pharmaceutical organization, based in Oost-Vlaanderen Belgium. The company uses medical and scientific expertise in all phases of the lifecycle of their products, continuing the growth of their company.
Role descriptionAs a self-employed regulatory affairs officer you will be occupied in the preparation of regulatory submission and make sure that these are followed up and updated in the system.
Responsibilities- Accountable for the making of regulatory submissions
- Providing product information
- Ensuring that reviews are conducted properly
- Ensuring that the regulatory submissions are followed up and that the system is updated
- Communicate and cooperate with external and internal stakeholders on all levels
Requirements- Knowledge of both local and European labelling + Middle East big plus
- Ability to make priorities
- Good presentation skills
- Bachelor degree
- Experience within a pharmaceutical or biotech industry
- Experience with European MAAs.
- Experience within regulatory legislation
- Good written and verbal skills in English and Dutch