CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences. For our client Janssen Vaccines & Prevention we are searching for a Consultant Regulatory Filing.
For Janssen Vaccines we are looking for an experienced Consultant Regulatory Filing. In this role you will be responsible for the molecular and bioassays and/ or analytical methods for products developed by Janssen Vaccines Leiden. In particular, you will be responsible for ensuring method validations meet the regulatory expectations and for translating Janssen Vaccines Leiden’s testing strategy 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, a strong sense of responsibility and a passion for quality are key competences for this position.
The ideal candidate has a PhD degree with Regulatory Affairs specialization. You have minimal 5 years of experience with regulatory filing for biopharmaceuticals and knowledge of method development and validation. Proven excellent writing skills is a must.
Project of at least one year, longer-term possibilities depending on budget approvals and proven added value. Full time preferred, 32 hours discussable.
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.
The Analytical Development department within Janssen Vaccines Leiden (one of the pharmaceutical companies of Johnson & Johnson) 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.
Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.
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