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
- Act as an expert and interface to the development department, marketing, production, quality department, and regional/local approval units
- Coordinate and communicate internationally within a global organization
What we expect?
- Successfully completed technical or scientific studies
- Experience in project management or change control processes
- Experience in regulatory affairs or a quality environment, preferably in a pharmaceutical/medical setting
- Knowledge of relevant regulations (such as registration of medicinal products, change control, GxP, EU requirements, CMC, ICH M4, etc.)
- Language skills: Fluent in English, advanced in German
- Structured and independent working style
- Strong communication skills
- Ability to work collaboratively in a team
- Assertiveness
Our offer to you:
Discover numerous opportunities at Fresenius, regardless of your expertise (m/f/d) and experience, for your professional future with purpose:
- The possibility to work remotely
- Contribute to making better medicines accessible worldwide
- Opportunities for self-directed career planning and professional growth
- A corporate culture encouraging innovative thinking to find the best solutions together
- A diverse team with a wide range of skills, talents, and experiences
- Benefits of a global corporation combined with the culture of a medium-sized company
- Support the department in cross-site activities to monitor product quality and regulatory compliance