Regulatory & Quality Compliance Manager (m/f/d) Position Available In Middlesex, Massachusetts

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
• EOE, disability/veterans

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