Manager 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 Noord-Holland Netherlands.
Our client is a multinational pharmaceutical company with focus on innovative, patient-centered medicines. The company is located in Nord-Holland.
ROLE DESCRIPTION
To strengthen the RA department, the company is currently looking for a (Sr.) Regulatory Affairs Manager. Your main task is to provide support for obtaining and maintaining commercial licenses.
RESPONSIBILITIES
Being involved in product registration procedures entails the following tasks:
- Write, compile and review registration documents
- Liaise with governmental authorities
- Risk assessment
- Contribute to strategical product development
- Provide support for related departments like marketing, medical affairs etc.
- Give training to registration assistants
Supporting activities:
- Responsible for budget/ costs for registration and state of affairs
- Develop and maintain SOP system for the registration department
REQUIREMENTS
- Bachelor degree in pharmacy or life sciences
- min. 3+ years' experience within Regulatory Affairs
- Profound knowledge of pharmaceutical laws and regulations
- Fluent in English (both written and spoken), able to communicate in Dutch
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.