What are the responsibilities and job description for the Regulatory & Quality Compliance Manager (m/f/d) position at Fresenius Medical Care?
The internal Job Title is called Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).
Main Responsibilities:
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:
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
- 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
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
