Ph3Regulatory Affairs Manager (m/f/d) - 12-month fixed-term contract /h3 h3bThe position /b /h3 pIn this role, you will represent the Regulatory Affairs Manager function within the Operative Units (OPUs) of Boehringer Ingelheim, covering a 12-month maternity leave. You will be responsible for executing all Drug Regulatory Affairs (DRA) activities in Switzerland, ensuring timely and successful product registrations in alignment with regional and local strategies. Furthermore, you will maintain the regulatory compliance and positioning of all registered and marketed products. You will implement and adhere to corporate procedures, as well as regional working instructions, processes, and systems relevant to these activities. In addition, you will contribute to local regulatory strategy and support compliance monitoring at the ROPU level. /p h3bTasks responsibilities /b /h3 ul liManage and oversee all local regulatory activities to ensure timely approvals and compliance with Swiss Health Authority requirements /li liMaintain close collaboration with Swiss Health Authorities, as well as regional and corporate DRA teams /li liRepresent the organization in local, regional, and global regulatory meetings /li liEnsure successful submission and maintenance of marketing authorizations, including variations, renewals, and safety reports /li liProvide regulatory input to support local strategy, labeling, and market access activities (e.g., pricing and reimbursement) /li liCollaborate cross-functionally with quality, pharmacovigilance, demand management, and other stakeholders to support product lifecycle and launches /li liMaintain accurate and up-to-date regulatory data in relevant systems and databases /li liOversee product complaint handling and recall processes in compliance with global and local procedures /li liCoordinate internal and external committees and ensure proper communication with authorities where required /li liSupport quality assurance activities, including preparation and review of product quality reports (PQRs) /li /ul h3bRequirements /b /h3 ul liProfessional experience in Regulatory Affairs /li liExperience in quality control and/or quality assurance in a GxP environment is an advantage /li liKnowledge of Swiss pharmaceutical (medicinal products) legislation /li liFluent in German and English, both written and spoken (French and/or Italian is a plus) /li liTeam player with a collaborative mindset /li liStructured and organized way of working /li libFlexible Working Model: /b pOpportunity for remote work and flexible working hours in alignment with your manager /p /li libLearning Development: /b pA broad range of training and development opportunities to support your personal and professional growth — because continuous learning is part of who we are /p /li libMental Health Support: /b pAccess to professional Employee Assistance Programs (EAP) and coaching services /p /li libCollaborative Work Environment: /b pA team‑oriented workplace characterized by strong mutual support and a culture of constructive collaboration /p /li /ul /p #J-18808-Ljbffr