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.

  • 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

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
  • Career level:
  • Professional Experienced
  • Job function:
  • Regulatory Affairs / Drug Safety
  • Working condition:
  • Permanent / Full-time
  • Business segment:
  • Fresenius Kabi
  • Location:
  • International / Eysins
  • Closing date for applications:
  • none - we look forward to your application
Karen Ibarra-Gonzalez
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 37799

We welcome diversity

At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.

All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).

Career with a purpose

Over 280,000 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.

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.

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

Your contact

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

Career level
Professional Experienced
Job function
Regulatory Affairs / Drug Safety
Working condition
Permanent / Full-time
Business segment
Fresenius Kabi
Location
International / Eysins
Closing date for applications
none - we look forward to your application

We welcome diversity

At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.

All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).

Career with a purpose

Over 280,000 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.

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