Regulatory Consultant
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 Zuid-Holland Netherlands.
Improving the access to medicines, making the best available treatment at an affordable price, starting in this entrepreneurial company will enrich your career!
Demonstrating flawless documentation, effective communication with varied levels of the organization with a strong sense of responsibility and a passion for quality are key competences for this position.
- 5 years' of experience with regulatory filing for bio-pharmaceuticals
- Knowledge of method development and validation
- Bio-pharmaceutical manufacturing
- Excellent writing skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.
The Company
Their mission is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented. In over 150 countries the company is bringing innovative science and together with the most creative minds in the industry think differently about diseases. Trying to achieve the best possible results for their health.Improving the access to medicines, making the best available treatment at an affordable price, starting in this entrepreneurial company will enrich your career!
Role Description
This department is responsible for the development of methods that are required for analysis of vaccines for human use. Analysis includes testing for identity, quantity, potency, purity and contamination. In particular; extraneous agents safety.Responsibilities
You will be responsible for the molecular and bioassays and/or analytical methods for products developed by this company. In particular; responsibility for ensuring method validations meeting the regulatory expectations and for translating testing strategies into company position papers and/or briefing books for health authority's scientific advice.Demonstrating flawless documentation, effective communication with varied levels of the organization with a strong sense of responsibility and a passion for quality are key competences for this position.
Requirements
- PhD. degree with publications and excellent writing skills- 5 years' of experience with regulatory filing for bio-pharmaceuticals
- Knowledge of method development and validation
- Bio-pharmaceutical manufacturing
- Excellent writing skills
Other information
Do you enjoy working in a multidisciplinary team?Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.
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