RA Manager Medicine and Global Labelling (m/w/d)

As a specialist in digestive and metabolic medicine and family businesses with global networking, we focus on the development and distribution of innovative medicines for various diseases of the liver, the bile ducts, the intestine and the esophagus to improve human life. We believe that we can only achieve medical progress together. So we are looking for: General responsibility for the preparation of the following scientific and regulatory documents (including scientific/substantive evaluation and coordination with the departments) Preclinical and clinical modules (modules 2.4-2.7, 4, 5) for new registrations, variations and renewals in the Central Process, DCP/MRP as well as worldwide national procedures and their matching with the applicable regulatory requirements Orphan Drug Designations, Paediatric Investigation Plans (PIPs) and Briefing Documents for Scientific Advices with National and International Authorization Authorities Letter of response to regulatory requirements during regulatory processes with regard to preclinical and clinical issues Interface to and interdisciplinary cooperation with other departments concerned (in particular medical science, preclinical and clinical research, drug safety) General coordination of scientific consultations with the approval authorities (Scientific Advices), Paediatric Investigation Plan (PIP) Procedures and Orphan Drug Designation Applications Regulatory support for development projects focusing on preclinical and clinical issues, PIPs, Orphan Designation and Scientific Advice, as well as the development of product information texts Coordination, creation, maintenance and steering of the following Falk products worldwide (in about 60 countries): Company Core Data Sheets (CCDS) Based on the creation and updating of the product information texts for regulatory processes (new registrations, variations, renewals etc.) Translation of texts into the respective national languages in cooperation with translation offices Content assessment of official text changes as well as official review of existing texts, evaluation of deviations and, where appropriate, Initiation and follow-up of corrective measures The holder of the job will assume the above-mentioned responsibilities for defined countries Cooperation with sales partners and subsidiaries worldwide in new registrations and lifecycle management Regulatory support for inclusion and extraction activities (Due Diligence) and the development of authorisation strategies Coordination and implementation of regulatory activities in the field of pharmacovigilance (e.g. PSUR filing) monitoring the regulatory environment; Analysis and implementation of new regulatory requirements

Pharmazeutin, medical researcherin, natural sciences*in Multiannual professional experience in Regulatory Affairs, optimally over 10 years but at least 7 years In-depth professional experience in labelling management and/or regulatory medical Writing (M 2.5/2.7) and/or creation of PIPs Advantages are first or deepened experiences with admission procedures in the USA (including pre-IND, IND phase) Knowledge of the medical nomenclature German and English knowledge (min. B2 level) in word and writing are required

New Work, flexible working hours and mobile work Various benefits such as Hansefit, Jobrad, Germanyticket, kindergarten grant and purchase of additional holiday days Comprehensive onboarding and mentoring program Individual training opportunities International and growing family business with short decision-making and financial independence For questions, Sabine Aicher is available by e-mail at personal@drfalkpharma.de or by telephone 0761 1514-253 (Monday to Thursday). We look forward to your application via our online portal. JOBV1_EN