Regulatory Affairs Manager Switzerland (m/f/d)

To support our Regulatory Affairs team in Switzerland, we are looking for a: Regulatory Affairs Manager Switzerland (m/f/d) for our location in Zürich at the earliest possible date in part-time (50%-60% workload). In this function, you will play a key role in ensuring the market authorization and compliance of our products. You will actively participate in regulatory processes, maintain close contact with authorities, and contribute to the continuous further development of our regulatory strategies. Your tasks: * Responsibility for compliance with all regulatory and legal requirements for medicinal products in Switzerland * Organization and monitoring of Swiss authorization processes * Development and implementation of authorization strategies for new products and existing portfolios * Responsibility for maintaining the authorizations of medicinal products registered in Switzerland (Life Cycle Management), evaluation of variation applications, and preparation of the required documents * Contact person for Swissmedic for the products within the area of responsibility * Active participation in European and global product-specific meetings, regular exchange with national and international Regulatory Affairs colleagues * Participation in European Regulatory F2F meetings * Cross-departmental cooperation with interfaces within the company * Observation of regulatory developments, development and implementation of required measures * Deputy for the Senior Regulatory Affairs Manager DACH Your profile: * Degree in a scientific discipline (pharmacy, biology, chemistry or other scientific education) * Several years of professional experience in dealing with Swissmedic authorizations and regulations * Knowledge of Swiss medicinal product law and regulatory requirements * Team player with strong communication skills as well as a structured, independent and solution-oriented way of working * Experience in cooperation with authorities, especially Swissmedic * Confident handling of Microsoft Office products as well as rapid familiarization with the required IT programs for the work area * eCTD knowledge is an advantage * German native language, very good English skills (French or Italian an advantage) Our offer: At Otsuka DACH, the advantages of a large corporation are combined with those of a small company. We benefit from financial security and infrastructure as well as direct decision-making paths and flat hierarchies. We all know each other personally, work together and support each other -- we are a team! A colorful palette of benefits awaits you, such as an Employee Assistance Programme, the option for additional days off or individual training opportunities. Your way to us: In the first step, please send your complete application documents stating your possible start date and your salary expectations preferably via [our homepage](< >). Should you have any questions about Otsuka or the vacancy, please feel free to contact Nicole Schuhbeck by e-mail. E-Mail: j4id10401081a j4it0938a j4iy26a