Regulatory Affairs Manager (m/f/d) - 12-month fixed-term contract
The position
In 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.
Tasks & responsibilities
- Manage and oversee all local regulatory activities to ensure timely approvals and compliance with Swiss Health Authority requirements
- Maintain close collaboration with Swiss Health Authorities, as well as regional and corporate DRA teams
- Represent the organization in local, regional, and global regulatory meetings
- Ensure successful submission and maintenance of marketing authorizations, including variations, renewals, and safety reports
- Provide regulatory input to support local strategy, labeling, and market access activities (e.g., pricing and reimbursement)
- Collaborate cross-functionally with quality, pharmacovigilance, demand management, and other stakeholders to support product lifecycle and launches
- Maintain accurate and up-to-date regulatory data in relevant systems and databases
- Oversee product complaint handling and recall processes in compliance with global and local procedures
- Coordinate internal and external committees and ensure proper communication with authorities where required
- Support quality assurance activities, including preparation and review of product quality reports (PQRs)Support quality assurance activities, including preparation and review of product quality reports (PQRs)Support quality assurance activities, including preparation and review of product quality reports (PQRs)
Requirements
- Professional experience in Regulatory Affairs
- Experience in quality control and/or quality assurance in a GxP environment is an advantage
- Knowledge of Swiss pharmaceutical (medicinal products) legislation
- Fluent in German and English, both written and spoken (French and/or Italian is a plus)
- Team player with a collaborative mindset
- Structured and organized way of working
- Strong communication skills
Your Benefits
- Flexible Working Model:
Opportunity for remote work and flexible working hours in alignment with your manager - Learning & Development:
A broad range of training and development opportunities to support your personal and professional growth — because continuous learning is part of who we are - Mental Health Support:
Access to professional Employee Assistance Programs (EAP) and coaching services - Collaborative Work Environment:
A team‑oriented workplace characterized by strong mutual support and a culture of constructive collaboration
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