Job Title: Regulatory & Quality Compliance Manager (m/f/d)
Job Location: Knoxville, TN, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
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
Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
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