Life Sciences Regulatory Affairs Consultant
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.
A global leader in innovation. At our client you get the chance to work on projects among a multi-sectorial portfolio of more than 300 products.
ROLE DESCRIPTION
Regulatory affairs in the pharaceutical sector is key to ensure the quality of their products, for precise clinical trials and patient safety.
RESPONSIBILITIES
You will mainly act as a Technical Writer for CMC parts of regulatory variations:
- Writing IMPDs as far as CMC is required
- Registration of files and variations for EU
- Writing Module 2 of regulatory files that can are to be submitted through eCTD Modules
Report to RA Director
REQUIREMENTS
MSc. in life science with relevant experience 2 years
At least 2 years of relevant experience in CMC writing
Fluent in English and Dutch
Manages coherence between quality and delivery volume
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
