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
  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Regulatory Affairs / Drug Safety
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Kabi
  • Standort:
  • International / Eysins
  • Bewerbungsfrist:
  • none - we look forward to your application
Karen Ibarra-Gonzalez
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 41157

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

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

Ihr Kontakt

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

Karrierelevel
Berufserfahrene
Einsatzbereich
Regulatory Affairs / Drug Safety
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Kabi
Standort
International / Eysins
Bewerbungsfrist
none - we look forward to your application

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

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