Regulatory Affairs Manager CMC (m/f/d)

Creation of pharmaceutical quality documents and dossiers for national and international admissions and registrations Assessment and evaluation of data and documents concerning their suitability for authorisation purposes Regulatory support of development projects Regulatory advice of internal specialist functions Regulatory assessment of change control requests Participation in scientific consultations

Completed scientific studies Multiannual professional experience in Regulatory Affairs Long-standing, operative experience in CMC Secure application knowledge in MS Office, ideally experience in dealing with document management systems and publishing tools Very good German – and English skills in word and writing Independent, structured, analytical and solution-oriented mode of operation Representative communicative skills, independent and independent work Teamability and reliability

A professional team that is passionate about shaping the growth course of our company. We value a respectful atmosphere and a motivating working environment. Cohesion & engagement, we live beyond the teams at our sports and events events. A modern production site that stands for quality and innovation. Attractive is our compensation package, which includes Christmas and holiday money and additional bonus options. Mobility means good transport connections, free parking, e-store columns and a certified German ticket. With our flexible working time models, we allow sliding time and (partial) home office in many business areas at 37.5 hours/week. In addition to our 30 days holiday you will receive paid allowances for special private events. We support you with free sports such as EGYM Wellpass and individual offers for your mental well-being. At our site you will find a modern and approved canteen with free drinks at any time. Once it becomes tight, we are at your side with a support offer for childcare and family care. .