RA Manager
Location: NetherlandsSIRE 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 Pharmaceutical organization, based in Noord-Holland Netherlands.
The company is a big international organisation and is one of the most innovative players in pharmaceutical and medical products worldwide.
ROLE DESCRIPTION
As Regulatory Affairs Manager you will be responsible for the registration of new and existing drugs in line with the laws and regulations focusing on CMC.
RESPONSIBILITIES
- Maintenance of obtained approvals
- The submission of registration dossiers and guiding the registration procedure
- Maintaining contact with the CBG
- Being responsible for the communication with other departments within the organisation
- The correct translation of product information
REQUIREMENTS
- University degree (WO) in the pharmaceutical, biomedical or equivalent sciences
- A minimum of 5 years work experience with regulatory affairs
- Excellent communication and writing skills in Dutch and English
- Excellent knowledge of current legislation and regulations in the Netherlands and the EU
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact .