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Project Manager & Associate Regulatory Affairs

Michael Page
Contratto a tempo indeterminato
    Sanofi Genzyme is one of the world's leading biotechnology organisations, recognised for their pioneering development of treatments for rare genetic disorders and their innovative contributions to medical science and bio-manufacturing. Our client focuses on rare diseases, multiple sclerosis, immunology and oncology. They help people with debilitating and complex conditions that are often difficult to diagnose and treat. The organisation is dedicated to discover and advance new therapies, providing hope to patients and their families around the world. As a Project Manager & Associate RA you will be located at the office of Sanofi Genzyme in Naarden, the Netherlands. This position will provide support for Chemistry Manufacturing and Controls (CMC RA) for licensed and clinical biological products. You will provide input into the product strategy for commercial and clinical teams. Incumbent you will be responsible for supporting the defined regulatory strategy, which is aligned with Health Authority requirements from a global perspective and supporting the on-time submission of quality regulatory filings. Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites, communication to senior management and working with supply chain as required to ensure business continuity is maintained. Furthermore, you will provide support for other CMC projects. Therefore there will be close collaboration with other colleagues, including RA CMC biologics global and regional product focal points: RA Africa, Middle East, Eurasia (AMEE), RA EU and affiliates. Key responsibilities:Newapplicationsforbiologics asrequiredperSanofi way of working: Plan/Prep/Submit/Review support for product dossiers including territory extensions CTA / IND preparation and maintenance License Maintenance Recurrent filings: (Renewals) Site registration and renewals (e.g. Gulf Cooperation Council) Post Approval Supplements Work with RA CMC Biologics global and regional product focal points to develop Regulatory strategy Support submission preparation/authoring/review per Sanofi way of working - including RA AMEE & EU follow-on countries aligned with reference country dossiers EU/US Technical Review of country specific information as required generated by sites (CoA, declarations, etc.) Project Management timely dispatch of dossiers via RA Ops and using Sanofi systems to affiliates Project Management responses to Health Authority questions for responsible region Interaction/liaise with RA EU, GRA AMEE Region and affiliates as required on CMC topics Change Controls Support change control completion as required by Global and regional product focal points per Sanofi way of working, in particular for complex changes requiring additional planning and input from affiliates Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations as required Bachelor's or Master's degree in a relevant subject (e.g. Life Sciences) A minimum of 3 years of relevant work experience in a highly regulated industry Fluent in English (verbal and written) Good scientific writing skills Proficient in MS Word, Excel, PowerPoint, MS Project, and IT Systems Experience of working in a matrix environment Excellent organisational, communication, negotiation and people skills Demonstrated ability to work successfully on project teams Analyse possible solution using standard procedures
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