Regulatory Affairs Director
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!
Our client is a professional Pharmaceutical organization, based in Brussel Belgium.
The company produces products to treat and visualize cancer.
Responsible lead of the new Regulatory Affairs (RA) department including two existing RA-groups.
- Ensure the timely compilation of regulatory dossiers for our active pharmaceutical ingredients (APIs)
- Furthermore you ensure regulatory compliance of our APIs.
- Expert for regulatory questions you collaborate with all internal and external stakeholders providing advice and appropriate decisions
- Master or PhD degree in life sciences or pharmacy
- A minimum of 5 years of experience in the fields of RA and leadership
- Very good knowledge of the registration requirements for pharmaceuticals (EU/US)
- Familiar with format (IMPD, CTD) and content (CMC) of regulatory dossiers
- Knowledge on eCTD
- Fluent in Dutch, English and French
- Independent, dedicated and initiative personality
- Excellent organizational and communication skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Linn Andenes.