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 requirements - Organization of submission-readiness of regulatory documentation (e.g., CMC relevant parts) - Organize and support global creation and maintenance of regulatory documentation - Management of global teams within change projects - Expert and interface function to the development department, marketing, production, quality department, as well as to the regional/local approval unit - International coordination and communication in a global organization What we expect? - Successfully completed technical or scientific studies - Experience in project management respectively change control process - Experience in regulatory affairs or in a quality environment, ideally in a pharmaceutical/medical environment of advantage - Knowledgeable 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 German-Structured and independent way of working-Strong communication skills-Ability to work in and with a team - Assertiveness Our 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 basis - Whether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the world - Individual opportunities for self-determined career planning and professional development - A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together - A large number of committed people with a wide range of skills, talents and experience - The benefits of a successful global corporation with the collegial culture of a medium-sized company - Supporting the department in cross-site activities to monitor product quality and regulatory compliance