Experienced Consultant Regulatory Filing | Biopharmaceuticals | Zuid-Holland
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 and Biotechnology organisation, based in Zuid-Holland Netherlands.
• Minimal 5 years of experience with regulatory filing for biopharmaceuticals
• Knowledge of method development and validation
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
The Company
They develop vaccines that are the first or best in their class and protect against some of the world's most life-threatening infectious diseases. The pathogens against which vaccines are developed include Ebola, Respiratory Syncytial Virus (RSV), Human Immunodeficiency Virus (HIV), Extra-intestinal Pathogenic E. coli (ExPEC), Methicillin-Resistant Staphylococcus Aureus (MRSA), polio and influenza.Role Description
The Analytical Development department is responsible for developing 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. You are responsible for the molecular and bioassays and analytical methods for products developed in Leiden.Responsibilities
You are responsible for ensuring method validations meet the regulatory expectations and for translating the testing strategy into company position papers and briefing books for health authority’s scientific advice. Demonstrating flawless documentation, effective communication with varied levels of the organization, 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• Minimal 5 years of experience with regulatory filing for biopharmaceuticals
• Knowledge of method development and validation
Other information
Please submit your application before the 20th of September.Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
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