Regulatory Affairs Officer
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 Groningen Netherlands.
Our client operates on a global scale and deals with active pharmaceutical ingredients (API) for human and veterinary medicines. The company focuses on R&D, manufacturing and distribution.
ROLE DESCRIPTION
The company offers a versatile function in which you are mainly responsible for compiling relevant product information and ensure correct registration.
RESPONSIBILITIES
- Develop and maintain active substance master files (ASMFs)
- Create and managing confidential disclosure agreements (CDAs)
- Supervise legal guidelines and advise internal organization in RA
- Liaise with stakeholders and health authorities
- Keep track of changes in laws and regulations
REQUIREMENTS
- Bachelor or Master degree in Life Sciences or Chemistry
- min. 3+ years' experience as Regulatory Officer
- Experience in a GMP environment, experiences with FDA is a plus
- Good communication skills in English, Dutch is a highly appreciated
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.
