Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products)
Regulatory & Quality Compliance Manager (m / f / d)
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Location :
Bad Homburg, Germany; Waltham, MA, USA; Guadalajara - Plant - RTG; Bogotá, CUN, CO; Knoxville, TN, USA
Time Type : Full time
Full time
Posted On : Posted 9 Days Ago
Posted 9 Days Ago
Job Requisition ID : R0158017
R0158017
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
- 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 :
- The opportunity to work on a mobile basis
- 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
- 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
About Us :
Our Work Experience is the combination of everything that's unique about us : our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people.
Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference.
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