Biography
Area of Practice: Jürgen has more than 30 years of experience in Regulatory Affairs, working for Schering AG heading the department of Global Regulatory Affairs Diagnostics and Radiopharmaceuticals, with Bayer Pharmaceuticals as Senior Global Strategist and for Piramal Imaging GmbH (later Life Molecular Imaging as Head of Global Regulatory Affairs and Pharmacovigilance. After his retirement in March 2020, he founded his own company for regulatory consultancy. During his work as regulatory professional he has managed successfully all kind of regulatory aspects and has obtained 6 marketing authorisations in the EU, USA and Japan. His special focus lies on the development and maintenance of diagnostic imaging products, in particular diagnostic radiopharmaceuticals, but he is also familiar in regulatory affairs of therapeutic products. He has worked in various cross-company working groups on regulatory guidelines and organized meetings with industry and health authorities about general topics Jürgen is familiar and experienced with all regulatory procedures in the EU (national, mutual recognition, decentralized and centralized procedures), has conducted several scientific advice meetings with EMA, CHMP and national health authorities as well with the FDA.
Education: Free University of Berlin – Graduation in pharmacy Ph.D. in pharmaceutical chemistry. Senate for Health and Social matters – Approbation as apothecary. Center for Biopharmaceutical Sciences of Leiden University and Institute for Pharmaceutical Business Administration – Graduation in Course for European Regulatory Affairs.
Professional Summary: Managing Partner Hirschfeld Regulatory Affairs Consulting GmbH Development of regulatory strategies for various clients Worked on several submissions to the EMA and FDA (Scientific advice, PIPs, orphan drugs) Senior Director, Head of Global Regulatory Affairs & Pharmacovigilance of Life Molecular Imaging GmbH (former Piramal Imaging) In his global responsibility for pharmacovigilance and all safety related aspects in drug development Jürgen supervised the QPPV and was member of the global safety company of the company. As member of the protocol review he was involved in the release of clinical studies In his global responsibility for Regulatory Affairs Jürgen supervised all regulatory activities of the company including interactions with the FDA, the EMA, and the Japanese Health Authorities. Director, Senior Global Regulatory Strategist, Bayer Pharma AG In this function Jürgen was team chair for several regulatory teams for Adcom Meetings in the USA and Referral Procedures (EMA) and co-chaired safety related task forces He was Bayer representative in several industry groups of the imaging industry, including industry working groups for comments on the revised EU diagnostic imaging guideline He was responsible for the Organisation of a molecular imaging symposium (MobiTech Initiative), holding lecture speeches representing the pharmaceutical company pojnt of view in several congresses and symposiums Head of GRA Diagnostic Imaging and Radiopharmaceuticals, Schering AG, Berlin In this function he supervised all regulatory imaging units of the Schering Group with functional responsibility for 15 regulatory managers and administrative responsibility for 8 regulatory managers, which includes the planning of the global budget and resources for the unit and the development of regulatory staff. He was responsible for the regulatory strategy for the development, maintenance or line extensions and represented the function in various management teams of Schering AG giving regulatory advice to all business related strategies and activities Head of Dossiermanagement Diagnostics, Schering AG, Berlin Jürgen supervised all regulatory activities in the European Union in diagnostic imaging and providing regulatory advice to Business Unit Diagnostics. He was responsible for resource allocation and budget planning and supervison of regulatory managers and integrated regulatory functions of newly acquired companies and organized input from the Schering Group into new guidelines for diagnostic agents Fachgruppenleiter, Dossiermanager Diagnostika and Scientific co-worker, Schering AG, Berlin In this function he was Regulatory Core Team Member in international project teams and contributed thereby to obtain and maintain marketing authorizations for new chemical entities and line extensions. As regulatory representative in cross-functional teams he contributed to the implementation of the medical device directive into the Schering AG
