Regulatory & Quality Compliance Manager

• Supporting the department in cross-site activities to monitor product quality and regulatory compliance

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