CMC Regulatory Affairs Manager
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 and Pharmaceutical organization, based in Noord-Brabant Netherlands.
Our client is a multinational biopharmaceutical company who aims to save and improve lives. The focus of the company is on research and development of innovative medicines.
ROLE DESCRIPTION
The company offers a challenging role as CMC Regulatory Affairs Manager.
RESPONSIBILITIES
- Definition of the registration strategy for submissions worldwide
- Preparation and submissions of registration dossiers
- Focus on technical writing of CMC Module 2-3
- Ensure regulatory compliance
- Contact person for Health authorities
- Keep up-to-date with governmental and worldwide requirements
- Work in multinational project teams
REQUIREMENTS
- MSc/ BSc degree life sciences, chemistry or a related discipline
- Min. 3 years' experience in regulatory affairs and project/product development
- Experience with writing of CMC documents
- Strong communication skills in English
- Extensive knowledge of MS Office, Trackwise is a plus
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.
