RA Manager Medicine and Global Labelling - limited to 2 years (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: Responsible coordination, creation, maintenance and steering of product information texts (SmPC, Pil, Labeling) of the Falk products worldwide within the framework of authorisation procedures and regulatory lifecycle procedures (e.g. Renewal, Variation etc.). Dr. Falk Pharma sells products in about 60 countries: the job owner will be responsible for defined countries within and outside the EEA Coordination of the translation of texts into the respective national languages in cooperation with translation offices and local partners Cooperation with sales partners and subsidiaries worldwide for new registrations and lifecycle management 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 Coordination and implementation of regulatory activities in the field of pharmacovigilance Creation, updating, maintenance of Company Core Data Sheets (CCDS) Cross-departmental cooperation within Dr. Falk Pharma as part of the initiation, implementation and logistical implementation of product information texts. monitoring the regulatory environment; Analysis and implementation of new regulatory requirements Working with the creation, review and implementation of internal processes in the field of label management Cooperation and support in 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

Pharmazeutin, physicianin, naturalist*in or comparable qualification Professional experience (approx. 3 to 5 years) in Label Management/Regulatory Affairs Knowledge of the medical nomenclature German and English knowledge in word and writing (min. B2 level)

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