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Regulatory and Government Affairs

Regulatory & Quality Compliance Manager (m/f/d)

Address:

  • Else-Kröner-Str. 1, Bad Homburg, HE 61352, Germany
  • 5105 S National Dr, Knoxville, TN 37914, United States of America
  • Block 15, 1036 Tianlin Road, Shanghai Business Park III, Minhang District, Shanghai, Shang Hai Shi 200233, China
  • Frankfurter Str. 6-8, St. Wendel, SL 66606, Germany
  • Headquarters, Waltham, MA 02451, United States of America
  • KM 1 Vía Siberia Funza ZF Intexzona LT 85, Bogotá, Bogotá 250017, Colombia
  • Paseo Del Norte 5300, Guadalajara, Jal. 45010, Mexico

Job ID: R0158017

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Job Description

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 GermanStructured and independent way of workingStrong communication skillsAbility 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

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