Director Regulatory Scientific Affairs (m/w/d)

61348 Bad Homburg
14.10.2019

Daten dieser Anzeige

Job-ID: 011403761
Director Regulatory Scientific Affairs (m/w/d)

Fresenius Kabi Deutschland GmbH

Germany

https://jobdb.softgarden.de/jobdb/public/jobposting/applyonline/click?jp=5112227

Responsible for the medical scientific content of regulatory dossiers for submissions worldwide, e.g. of marketing authorisation applications (MAA), variations, renewals of MA: Organisation and review of Non-clinical & Clinical Overviews (Modules 2.4 & 2.5), if applicable in cooperation with external service providers Medical scientific input and support of Regulatory Affairs BU Generics and Complex Formulations during regulatory procedures, e.g. MAAs, variations and renewals of MAs Compilation of "Addendum to the Clinical Overview" or "Clinical Expert Statement" for renewals of MAs in cooperation with Pharmacovigilance Medical risk assessment in support of the BU Generics and Complex Formulation's portfolio team including assessment of changes of the product information and provision of suitable text modules Medical scientific risk assessment for marketed products of the BU Generics and Complex Formulations Medical assessment during due-diligence for in-licensing projects Representative of the BU Generics and Complex Formulations in the Fresenius Kabi medical scientific community including internal decision-making bodies with respect to product information updates

  / 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 Scientific Affairs (m/w/d) Your assignments Responsible for the medical scientific content of regulatory dossiers for submissions worldwide, e.g. of marketing authorisation applications (MAA), variations, renewals of MA: Organisation and review of Non-clinical & Clinical Overviews (Modules 2.4 & 2.5), if applicable in cooperation with external service providers Medical scientific input and support of Regulatory Affairs BU Generics and Complex Formulations during regulatory procedures, e.g. MAAs, variations and renewals of MAs Compilation of "Addendum to the Clinical Overview" or "Clinical Expert Statement" for renewals of MAs in cooperation with Pharmacovigilance Medical risk assessment in support of the BU Generics and Complex Formulation's portfolio team including assessment of changes of the product information and provision of suitable text modules Medical scientific risk assessment for marketed products of the BU Generics and Complex Formulations Medical assessment during due-diligence for in-licensing projects Representative of the BU Generics and Complex Formulations in the Fresenius Kabi medical scientific community including internal decision-making bodies with respect to product information updates Your profile Academic scientific degree in human medicines Several years of professional experience in Medical Scientific within a Pharmaceutical Company or CRO Basic knowledge and understanding of the regulatory environment in the field of generic products Ability to communicate clearly and effectively, analytical skills, pays attention to detail Capability to manage multiple priorities in an efficient manner; well organized, able to work in an international team environment Business-fluent in English Apply now Send via email Print this page At a glance Career level: Professional Experienced Job category: Medicine Working condition: Permanent contract / Full-time Business segment: Fresenius Kabi Location: Bad Homburg / Hessen Closing date for applications: none - we look forward to your application Apply now Send via email Print this page Your contact Teresa Martin Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 34900 About Fresenius Career with a purpose: Over 270,000 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 Teresa Martin Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 34900 fresenius-kabi.com Career level: Professional Experienced Job category: Medicine Working condition: Permanent contract / Full-time Business segment: Fresenius Kabi Location: Bad Homburg / Hessen Closing date for applications: none - we look forward to your application About Fresenius Over 270,000 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

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Medizinische Tätigkeiten/ Gesundheits-/ Sozialwesen

Medizintechnik/ Optik

Bereichs-/ Abteilungs-/ Gruppenleitung

Vollzeit

61348 Bad Homburg