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 Zuid-Holland Netherlands.
Our 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 Officer in Fulltime.
In this position your are mainly responsible to achieve approvals for API registration dossiers in the EMEA market.
RESPONSIBILITIES
- Preparation, submission and maintenance of API registration dossiers
- Change Management
- Interaction with customers by way of regulatory matters
- Regular review of upcoming guidelines and compliance
REQUIREMENTS
- Academic degree in Chemistry or Pharmacy
- 3+ year's experience in Regulatory Affairs of APIs
- Profound understanding and experience with registration procedures
- Experience with IT tools like EDMS, share point and eCTD
- Excellent command of English, both verbally and written
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.
