RA Manager CMC / non-EU part-time 50% - limited to 2 years (m/f/d)

Your duties Dosing and support of new registration procedures in cooperation with international partners including follow-up of submissions Creation and updating of pharmaceutical approval documentation (Module 3, QOS) for stock and development products Processing of authorisation extensions, modification procedures and deficiencies from the above procedures and monitoring of deadlines Cooperation in the development and implementation of global regulatory strategies and coordination of regulatory processes and projects. Regulatory Accompanying Product Lifecycle Management and Change Control Projects and Ensuring Regulatory Implementation of Changes Monitoring regulatory requirements and ensuring regulatory compliance in supervised countries, maintaining databases Cooperation with external bodies such as authorities, international partners, wage producers and consultants Participation in the introduction, optimization and standardization of processes in Regulatory Affairs

Your qualification Successfully completed study of pharmacy or natural sciences Multiannual professional experience in Regulatory Affairs Extensive experience in the production and maintenance of pharmaceutical documentation Knowledge of the national and international regulatory environment and drug law Very good knowledge of German and English in word and writing Analytical thinking and a structured and self-responsible way of working High level of initiative, flexibility and resilience Embossed team and communication skills High reliability, independent and careful operation Safe handling of M365 applications Ideally experience with submission management systems such as docuBridge

Your advantages 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 via e-mail at personal@drfalkpharma.de or under the phone number 0761 1514-253. We look forward to your application via our online portal.