The internal Job Title is called Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).Main Responsibilities:Support as regulatory expert development and new registration projects (Medicinal Products)Project management for the implementation of projects to comply with regulatory requirementsOrganization of submission-readiness of regulatory documentation (e.G., CMC relevant parts)Organize and support global creation and maintenance of regulatory documentationManagement of global teams within change projectsExpert and interface function to the development department, marketing, production, quality department, as well as to the regional/local approval unitInternational coordination and communication in a global organizationWhat we expect?Successfully completed technical or scientific studiesExperience in project management respectively change control processExperience in regulatory affairs or in a quality environment, ideally in a pharmaceutical/medical environment of advantageKnowledgeable in relevant regulations (such as registration of medicinal products, change control, GxP, EU requirements, CMC, ICH M4, etc.
)Language requirements: Fluent in English, advanced in GermanStructured and independent way of workingStrong communication skillsAbility to work in and with a teamAssertivenessOur offer to you:There is a lot for you to discover at Fresenius, because we have a lot to offer.
No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:The opportunity to work on a mobile basisWhether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the worldIndividual opportunities for self-determined career planning and professional developmentA corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution togetherA large number of committed people with a wide range of skills, talents and experienceThe benefits of a successful global corporation with the collegial culture of a medium-sized companySupporting the department in cross-site activities to monitor product quality and regulatory compliance#J-18808-Ljbffr