Regulatory Affairs Manager — Swiss Submissions Lead (Fixed-Term)

Merck Group; Zug; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

Merck Group in Zug, Switzerland, is seeking a Regulatory Affairs Manager on a fixed-term contract (1.1.2027–31.03.2028) to cover maternity leave. You will drive submission strategies for marketing authorizations and life-cycle management for medicinal products, ensuring timely, compliant regulatory work.

You will collaborate with the Head Regulatory Affairs and Global Regulatory Affairs, liaising with authorities and internal experts to ensure high-quality outcomes.

Qualifikationen

• University degree in pharmacy, medicine or natural sciences.
• At least 5 years of experience in regulatory affairs in Switzerland.
• Analytical and strategic mindset.
• Independent, committed and detail-oriented.
• Fluent in German and very good English.
• Experience with e-CTD submissions and review of promotional materials is an advantage.

Aufgaben

• Develop submission strategy for marketing authorization of new medicinal products.
• Oversee lifecycle management of currently registered medicinal products.
• Ensure timely regulatory tasks with compliance to regulations and guidelines.
• Review promotional materials for regulatory compliance.
• Maintain contacts with authorities and internal/external stakeholders.

Kenntnisse

Regulatory affairs

Analytical mindset

Independent worker

Detail-oriented

Team player

Stakeholder management

German fluent

English fluent

Ausbildung

University degree in pharmacy/medicine/natural sciences

Jobbeschreibung

Merck Group in Zug, Switzerland, is seeking a Regulatory Affairs Manager on a fixed-term contract (1.1.2027–31.03.2028) to cover maternity leave. You will drive submission strategies for marketing authorizations and life-cycle management for medicinal products, ensuring timely, compliant regulatory work.

You will collaborate with the Head Regulatory Affairs and Global Regulatory Affairs, liaising with authorities and internal experts to ensure high-quality outcomes.