Regulatory Affairs Associate - CRO
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 Groningen Netherlands.
The company is a clinical research organisation (CRO) with drugs approval in several theraputic areas.
As a regulatory affairs associate you will support the company in obtaining Marketing Authorisation for products, and to maintain authorisations post-approval.
- Support in the preparation of regulatory submissions such as clinical trials applications, IND submissions and amendments, variations, renewals, support for marketing applications etc.
- Participate in the approval of promotional material as required and helping to resolve external medical/technical enquiries, when required.
- Attend working teams and providing regulatory input to these teams including preparation of draft position papers on regulatory issues, draft regulatory sections of project plans and to develop regulatory strategies .
- Bachelor degree in a life science/clinical field
- At least 3 years of experience with RA in the pharmaceutical industry
- Excellent communication and writing skills in English
- You are self-motivated and a quick learner
- Eye for detail is essential
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.