/ CAREER WITH A PURPOSE /

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.

Director Regulatory Affairs CMC Biosimilars

With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

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With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

Your assignments

  • Provides global leadership regarding management of submission CMC related documents and CMC regulatory data for Biosimilars.
  • Develops CMC regulatory strategy for assigned projects
  • As Business partner to the Biosimilar CMC team develops, supervises and manages the CMC regulatory activities and CMC submission strategy of Biosimilar dossiers and submissions that best serve the biosimilars business needs.
  • Translate CMC data in regulatory CMC positioning to create a comprehensive story line and CMC dossier
  • Act as RA CMC lead for development projects
  • Manage, supervise and develop senior managers for assigned projects

Your profile

Education

  • Degree in a Life Science or related discipline and possible higher degree

Work experience

  • At least 10 years pharmaceutical experience of which at least 8 years in international regulatory with focus on CMC in Biologics
  • Experience in managing a full initial marketing application submission or IMPD/INDs
  • Experience in preparation and coordination of regulatory strategy plans
  • Experience in interaction with regulatory agency in agency meetings for the major agencies (EMA/FDA)
  • Experience in analytics or drug substance process development for new biological entities
  • Experience in development of new biologicals or biosimilars

Job-specific competencies & skills

  • Excellent spoken and written English. A second major language would be an advantage.
  • Excellent written and spoken communication skills
  • Excellent interpersonal skills
  • Understanding of Regulatory Affairs contribution to Pharma business
  • Good organizational and planning skills
  • Ability to think strategically
  • Ability to lead and work in teams

At a glance

Career level:

Professional Experienced

Job category:

Regulatory Affairs / Drug Safety

Working condition:

Permanent / Full-time

Business segment:

Fresenius Kabi

Location:

Eysins / International

Closing date for applications:

none - we look forward to your application

Your contact

  • Karen Ibarra-Gonzalez
  • Fresenius Kabi SwissBioSim GmbH
  • Fresenius Kabi SwissBioSim GmbH
  • Ref. number: 37799

About Fresenius

Career with a purpose:

Over 290,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.

career.fresenius.com
fresenius.com

 

One of Fresenius' strengths:

our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.

More reasons

 

The benefits we offer:

Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.

More benefits

Your contact

  • Karen Ibarra-Gonzalez
  • Fresenius Kabi SwissBioSim GmbH
  • Fresenius Kabi SwissBioSim GmbH
  • Ref. number: 37799
Career level:

Professional Experienced

Job category:

Regulatory Affairs / Drug Safety

Working condition:

Permanent / Full-time

Business segment:

Fresenius Kabi

Location:

Eysins / International

Closing date for applications:

none - we look forward to your application

About Fresenius

Over 290,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
career.fresenius.com
fresenius.com

One of Fresenius' strengths:

our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.

More reasons
The benefits we offer:

Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.

More benefits