Enkhuizen, North Holland, Netherlands
I have a genuine interest in science, biologicals manufacturing, and international affairs. I am calm and relaxed in general and resilient in stressful situations. I work hard to meet deadlines and deliver on promises. I am good at building relationships and solve problems diplomatically and pragmatically. My Insights Discovery Profile is blue.
Contributing to the strategic and operational activities required for regulatory compliance and registration of our biological products worldwide.
* Responsible for the extraneous agents safety of products developed by Janssen Vaccines Leiden. * Responsible for translating the company's extraneous agents safety strategy into company position papers (briefing books) for health authority’s scientific advice.
★ Licencing of veterinary in-vitro diagnostic test kits, EU, North America ★ Compiling technical reports and regulatory dossiers for major veterinary infectious dieases, BSE veterinary diagnostic products. ★ Supporting Bovine and Avian Tuberculin PPD regulatory submissions ★ Subject matter expert biosafety, import biological materials, GMO, technical writing ★ Member of the Site Leadership Team
★ Manage animal test facility performing safety and efficacy studies for candidate poultry vaccines in compliance with company requirements and applicable regulations. ★ Obtained GLP Endorsement of Compliance ★ Member of the Site Management Team ★ Site transfer of poultry vaccines manufacturing (egg-based production). ★ Regulatory Affairs expertise for study design and dossier compilation