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Regulatory Affairs Manager (m/f/d) - 12-month fixed-term contract

Boehringer Ingelheim (Schweiz) GmbH -
Basel, BS

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%

Leistungen

Eltern-/Erziehungsurlaub

Qualifikationen

Französisch
Englisch
Qualitätssicherung
Qualitätskontrolle
Italienisch
Kommunikationsfähigkeit
Deutsch

Vollständige Stellenbeschreibung

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

We are looking forward to receiving your application online!

By uploading your application documents via our application portal, we can treat your data confidentially and in compliance with the GDPR.

On our career site you will find further information about Boehringer Ingelheim as an employer as well as information about the application process and our different departments.

Would you like to know what makes our employees special? What they tell about their motivation and their everyday work? Watch this video and hear for yourself what our colleagues have to share.

Jetzt bewerben

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