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

26.03.2021

Daten dieser Anzeige

Job-ID: 020869759
Director, International Regulatory Affairs Biosimilars (m/f/d)

Fresenius Kabi

Germany

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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

About Fresenius / 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, 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 Apply now  Share by email  Print this page Your Contact Karen Ibarra-Gonzalez Fresenius Kabi SwissBioSim GmbH Ref. number: 41157 >  fresenius-kabi.com 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 About Fresenius 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.>  career.fresenius.com >  fresenius.com One of Fresenius' strengths: our corporate culture for "entrepreneurs in an enterprise" where you can quickly take on responsibility. The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. >  More reasons >  More benefits Fresenius Kabi SwissBioSim GmbH https://files.relaxx.center/kcenter-google-postings/kc-18740/logo_google_kabi.png 2021-05-25T09:45:38.287Z FULL_TIME YEAR null Eysins 1262

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Unternehmensführung/ Management

Sonstige Branchen

Medizintechnik/ Optik

Bereichs-/ Abteilungs-/ Gruppenleitung

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