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Rudolstadt - Regulatory Affairs Project Manager (f/m)

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Rudolstadt - Pharma - Manager - Sandoz

Stellenbeschreibung As part of the Sandoz Development Center Aeropharm GmbH in Rudolstadt, you will lead, communicate and manage the strategic setup and decision on the regulatory part for all allocated development projects. You will represent the regulatory function of the Development Regulatory Center (DRC) in the global regulatory community. The role requires a strong commitment to take responsibility for all regulatory affairs topics in global development teams. You will support the team with strong strategic focus, quality awareness and regulatory expertise. You will take responsibility for the proactive communication of the overall regulatory project strategy, key issues and any other critical topics in a timely manner to the local project leader, line manager and customers. The coordination of the compilation and the regulatory compliance of Module 2-5 for the products developed is one of your main responsibilities. A part from keeping knowledge up to date with regards to guidelines and regulatory as well as technical trends, you will have to ensure the Implementation of global and local regulatory requirements in the development process Mindestanforderungen • Academic degree in Science or relevant discipline • Advanced experience as leader of interdisciplinary project ...


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