Regulatory Affairs Manager
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands.
Main responsibility include obtaining and maintaining of commercial product licenses.
- Write, compile and review registration documents
- Risk assessment
- Liaise with governmental authorities
Expert role:
- Contribute to strategical product development
- Provide support for related departments like marketing, medical affairs etc
- min. 3+ years' experience in Regulatory Affairs
- Up-to-date knowledge of pharmaceutical laws and regulations
- Excellent command of English AND Dutch, both spoken and written
The Company
The company operates on an international level and focuses on innovative, patient-oriented medicines. The company's headquarter is in the Alkmaar-area.Role Description
To support the RA department, the company is currently offering a full-time position as Senior Regulatory Affairs Manager.Main responsibility include obtaining and maintaining of commercial product licenses.
Responsibilities
Product registrations:- Write, compile and review registration documents
- Risk assessment
- Liaise with governmental authorities
Expert role:
- Contribute to strategical product development
- Provide support for related departments like marketing, medical affairs etc
Requirements
- Master degree in the direction of pharmacy or science- min. 3+ years' experience in Regulatory Affairs
- Up-to-date knowledge of pharmaceutical laws and regulations
- Excellent command of English AND Dutch, both spoken and written
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