Your main tasks: You are responsible for Regulatory support of a defined portfolio in the area of medicinal products You ensure timely and high-quality preparation of marketing authorization dossiers You are responsible for Planning, implementation and coordination of marketing authorization applications in Europe Strategic planning and implementation of measures to ensure existing marketing authorizations in and outside Europe comply with the law Establishing and maintaining relationships with regulatory authorities and relevant third parties You are supporting the local market units in terms of regulatory tasks You participate in projects by contributing regulatory expertise Monitoring the regulatory environment and assessing its relevance for the product portfolio Your profile: You hold a University degree in sciences You have at least 3 years of work experience in European and international drug regulatory affairs You bring a sound knowledge of pharmaceutical regulations and directives in the EU You have the ability to work independently and autonomously You are structured working style, detail-oriented, team player, problem solver You have a high level of precision and strategic thinking You have a very good communication skills You are fluent in the English language (written & spoken), German language skills are an advantage Good IT skills Interest in regulatory IT topics