Global Regulatory Affairs Manager - API's
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 professional Pharmaceutical organization, based in Utrecht Netherlands.
One of the global leaders in antibiotics.
ROLE DESCRIPTION
In this role you will be responsible for the API registration dossiers of our client.
RESPONSIBILITIES
- Writing and reviewing dossiers - module 3 (CMC)
- Involved with the regulatory strategies
- Submissions of registration dossiers
- Get in contact with regulatory authorities
REQUIREMENTS
- Preferably a university degree in chemistry or pharmacy
- 3-5 years’ experience with regulatory affairs and API's
- Knowledge of registration procedures in the EU and US
- Preferably knowledge of different IT tools such as eCTD and share point
- Fluency in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Linn Andenes.
