Director CMC
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 Biotechnology organization, based in Zuid-Holland Netherlands.
The client is a international pharmaceutical company.
ROLE DESCRIPTION
As the director global CMC you are responsible for the regulatory strategy and bring it line with the global strategy. Your main tasks are related to antibodies and vaccines that are in clinical stage and post market.
RESPONSIBILITIES
You are responsible for a group of 8 people and have 3 managers directly reporting to you. You guide the group with interpretations and application of regulations; you help prepare the clinical trial applications; you are the point of contact for third parties and authorities.
REQUIREMENTS
- MSc degree in pharmacy, chemistry or biology
- Strong affinity with monoclonal antibodies
- Knowledge of vaccines is a big plus
- Direct regulatory experience in biotech products a great plus
- EU and FDA regulation knowledge
- Team player attitude that keeps his colleagues in mind
- Leader with clear communication skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Naut van Osnabrugge.
