Regulatory Affairs Coordinator
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 Zuid-Holland Netherlands.
Out client is a global leading manufacturer of APIs. Their mission is to provide high quality and reliable products by continuously exploring new technologies.
ROLE DESCRIPTION
To support the RA department, the company is currently looking for a Regulatory Affairs Coordinator in Fulltime (80-100%).
In this position you support the RA team in their daily activities and contribute positively to obtain and maintain global approvals for the company's products.
RESPONSIBILITIES
- Preparation of regulatory submissions
- Compiling the regulatory documents in eCTD and NEES
- Keep track of CEP tracking system
- Coordination and answering of regulatory/ administrative questions from customers
- Secretary tasks
REQUIREMENTS
- MBO/HBO education level
- 3+ years' experience as RA assistant, publisher or coordinator
- Profound knowledge of eCTD/ Nees, document management systems and databases
- Excellent command in English, both written and verbally
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Anja Paetel.
