Consultant Regulatory Affairs
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 consultancy and CRO operating on an international level. Most of the clients the company deals with are from the pharmaceutical and medical device industry.
ROLE DESCRIPTION
To support their Regulatory Affairs team, the company is currently looking for a Consultant Regulatory Affairs. In this role you will provide regulatory guidance and expertise in the field of biological products.
RESPONSIBILITIES
- Preparation, review and management of regulatory documents (like IMPD and CMC Module 3)
- Clinical Trial Applications, Marketing Authorizations and Post-Marketing Variations
- Liaison with regulatory authorities
- Project Management
- Close cooperation with other departments regarding the manufacturing and production processes of the biological products
REQUIREMENTS
- Academic degree in life sciences or pharmacy
- Min. 5+ year's experience in Regulatory Affairs
- Excellent knowledge of regulatory guidelines for EMEA region
- Good communication skills in Dutch and English
- Excellent project management skills
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.