Director, International Regulatory Affairs Biosimilars (m/f/d)

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.

  • Own the RA strategy and provide leadership for APAC, LATAM, MENA Region submission roll out and maintenance
  • Represent the International Regulatory Affairs Group at cross functional or intercompany committees, including the Life Cycle Activity Committee
  • As a Business partner to the Fresenius Kabi Regional Organizations and Biosimilar Commercial and Supply Chain teams, develop, supervise and manage international regulatory strategies and activities in alignment with other RA functions
  • Represent Fresenius Kabi SwissBioSim in international forums and congresses pertaining International Regulatory Affairs matters
  • May act as International RA lead for development projects, member of the RA subteam
  • Manage, supervise and develop the members of the International Regulatory Affairs team
  •  Provide International Regulatory Affairs expertise on Biosimilars for assigned development projects and support education of local affiliates and Regulatory Agencies on Biosimilars.
  • Manage the completion of the relevant documentation to allow timely submissions for the assigned products/countries
  • Manage, plan and timely finalize responses to questions from Authorities
  • Prepare or oversee preparation of briefing books and lead and provide support at Regulatory agencies meetings for the assigned regions
  • Ensure that Change Control Proposal (CCP) consider the implications for respective regions
  • Support business development opportunities/due diligence

Education

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

Work experience

  • At least 10-12 years pharmaceutical experience of which at least 8 years in international/regional regulatory affairs, ideally including Biologics/Biosimilar experience
  • Experience in managing submission roll out for initial marketing authorization applications and life cycle management submissions
  • Experience in interaction with regulatory agency in agency meetings for APAC, LATAM, MENA regions (e.g. ANVISA, HSA, MFDS, NMDA etc)

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
  • Career level:
  • Professional Experienced
  • Job function:
  • Regulatory Affairs / 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: 41157

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 300,000 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, International Regulatory Affairs Biosimilars (m/f/d)

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

  • Own the RA strategy and provide leadership for APAC, LATAM, MENA Region submission roll out and maintenance
  • Represent the International Regulatory Affairs Group at cross functional or intercompany committees, including the Life Cycle Activity Committee
  • As a Business partner to the Fresenius Kabi Regional Organizations and Biosimilar Commercial and Supply Chain teams, develop, supervise and manage international regulatory strategies and activities in alignment with other RA functions
  • Represent Fresenius Kabi SwissBioSim in international forums and congresses pertaining International Regulatory Affairs matters
  • May act as International RA lead for development projects, member of the RA subteam
  • Manage, supervise and develop the members of the International Regulatory Affairs team
  •  Provide International Regulatory Affairs expertise on Biosimilars for assigned development projects and support education of local affiliates and Regulatory Agencies on Biosimilars.
  • Manage the completion of the relevant documentation to allow timely submissions for the assigned products/countries
  • Manage, plan and timely finalize responses to questions from Authorities
  • Prepare or oversee preparation of briefing books and lead and provide support at Regulatory agencies meetings for the assigned regions
  • Ensure that Change Control Proposal (CCP) consider the implications for respective regions
  • Support business development opportunities/due diligence

Your profile

Education

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

Work experience

  • At least 10-12 years pharmaceutical experience of which at least 8 years in international/regional regulatory affairs, ideally including Biologics/Biosimilar experience
  • Experience in managing submission roll out for initial marketing authorization applications and life cycle management submissions
  • Experience in interaction with regulatory agency in agency meetings for APAC, LATAM, MENA regions (e.g. ANVISA, HSA, MFDS, NMDA etc)

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

Your contact

Karen Ibarra-Gonzalez
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 41157

Career level
Professional Experienced
Job function
Regulatory Affairs / 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 300,000 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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