Product Manager Regulatory Affairs Monoclonal Therapeutics jobs at Msd in Netherlands
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Manage the Technicians and Reliability Engineers;. Manage the maintenance shutdown plans, in close the cooperation with the Shopfloor scheduler and TechOps / Engineering;. Monitor daily processes, highlight potential incidents and...
Develop and implement comprehensive global regulatory strategies for biologics, ensuring alignment with FDA, USDA, and other relevant agencies across all major regions and international markets. Define and execute the regulatory...
Project management of significant Digital workstreams on large capital projects or full Digital accountability on smaller ones across mainland Europe. Collaborating with internal stakeholders and external partners to deliver projects....
Manages implementation of global and regional strategies and processes through proactive partnership with the sites. Links the site and/or represents the site in the integrated business planning (IBP) process, focusing...
Degree in Engineering, Science or Supply Chain Management. Extensive and diverse experience in an international manufacturing organization with multiple locations and a wide range of products, leading to strongly developed...
Providing state of the art dossiers, variation and renewal packages for licensing of new Biological products and maintenance of the existing biological product portfolio. Providing veterinary regulatory expertise for new...
Responsibility for implementing and maintaining data quality (meta data and master data) in Alexx (Veeva Vault Regulatory Information Management System (RIM)) related to regulatory procedures and submissions. Validatingcompleteness and relevancy...
Manage the Technicians and Reliability Engineers;. Manage the maintenance shutdown plans, in close the cooperation with the Shopfloor scheduler and TechOps / Engineering;. Monitor daily processes, highlight potential incidents and...
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