Regulatory Affairs & Quality Manager (m/f/d)

As Regulatory Affairs & Quality Manager (m/f/d), you will take on a central position in ensuring the regulatory and quality-relevant requirements for our Swiss product portfolio. In doing so, you will work closely with local colleagues as well as international functions and make an important contribution to the provision of innovative therapies for patients. Your tasks Regulatory Affairs • Preparation, submission and follow-up of marketing authorization applications for new medicinal products and new indications in cooperation with international regulatory affairs teams • Creation and coordination of variations, renewals as well as other life-cycle management activities • Communication with Swissmedic and coordination of regulatory inquiries • Maintenance and updating of professional and patient information as well as coordination of internal approval processes • Ensuring the timely implementation of regulatory changes in packaging materials and product information • Advising internal specialist departments on regulatory issues and supporting the creation of information and marketing materials Quality Management • Deputy for the technically responsible person (FvP) for the Swiss market • Support in the market release of medicinal products as well as in the processing of complaints and returns • Participation in the further development and maintenance of the local quality management system • Performance and documentation of quality-relevant training • Support during audits, inspections and the implementation of resulting measures Cross-functional Support • Processing, coordination and documentation of inquiries and answers regarding regulatory and quality-relevant topics • Support for the Market Access department in cost coverage procedures according to Art. 71 KVV as well as associated administrative processes Your profile • University degree in pharmacy, natural sciences or a comparable qualifying education • Several years of professional experience in the field of Regulatory Affairs • Knowledge of the Swiss medicinal product and authorization environment as well as experience in dealing with Swissmedic • Ideally initial experience in quality management and knowledge of relevant GMP or GDP requirements • Structured, precise and analytical way of working • Ability to manage several projects simultaneously and reliably meet deadlines • High level of initiative, flexibility and solution orientation • Strong teamwork and communication skills as well as enjoyment of cross-functional collaboration • Very good German and English skills Are you enthusiastic about regulatory tasks as well as quality management and want to work in a varied field of activity? Then please send us your complete application documents via our [career portal](< >) . We look forward to meeting you! You are welcome to get a first impression to get to know our company culture better. j4id10432483jm j4it1041jm j4iy26jm