Manager Global Regulatory Affairs – Chemistry, Manufacturing and Controls (m/w/d)

As a dynamically growing pharmaceutical company, we are committed to the most valuable good of people – health. We work with more than 2,000 employees worldwide to improve the quality of life of patients (m/w/d). We specialize in the development and production, distribution and marketing of pharmaceutical products and diagnostics in the fields of rheumatology, urology, hematology and oncology. Our work is far more than a job: we really want to do something. At our location in Wedel near Hamburg we are looking for you as Manager (m/w/d) Global Regulatory Affairs – Chemistry, Manufacturing and Controls.

Creation, updating and content release of global CMC dossiers Development and maintenance of export or transportable authorisations Definition of regulatory requirements for pharmaceutical quality Participation in the production of CMC relevant manufacturer documentation Ensuring uniformity between regulatory and quality documentation Development of regulatory strategy options with regard to CMC-relevant assets

Approbation as a pharmacist (m/w/d) or a degree in science Multiannual professional experience and practical knowledge in the regulatory sector with a focus on global CMC dossiers First know-how in the guidance of support functions English in word and writing

Flexible and independent – In many business areas, our employees can freely divide their working hours – and work up to 60% remotely Recreation – 30 days a year and holiday allowance Special performance deserves special appreciation – At medac, all employees are involved in success-based premiums. Optimum provision – with occupational pensions and asset-effective benefits Attractive additional services – from corporate benefits to accident insurance to external employee advice The medac Academy offers a wide range of training courses, including language courses and e-learnings. Healthy food from regional cuisine – In our farm restaurants in Wedel and Tornesch there is a variety of delicious dishes every day By train to work – No problem, we grant the German ticket and the possible business bike leasing for maximum flexibility Fit and healthy – We offer a wide range of sports activities and health services: from business sports to relaxation courses to mobile massage JOBV1_EN