Strategic Regulatory Manager, Medicines (Switzerland)

Merck Healthcare; Zug; Vor Ort; CHF 140.000 - 180.000; Vollzeit

Zusammenfassung

Merck Healthcare in Zug is seeking a Regulatory Affairs Manager on a fixed-term basis to support the maternity leave covering 1 January 2027 to 31 March 2028. You will lead regulatory submissions strategy for new medicinal products and lifecycle management while ensuring compliance with local laws and guidelines.

The role requires collaboration with Head Regulatory Affairs, global teams, and authorities, with deep focus on promotional material review and regulatory strategy.

Qualifikationen

• University degree in pharmacy, medicine or natural sciences.
• At least 5 years' experience in regulatory affairs in Switzerland.
• Analytical and strategic mindset.
• Able to work independently with commitment and accuracy.
• Flexible and able to work under pressure.
• Team player with strong stakeholder interaction.
• Fluent in German with very good English skills.
• Experience with e-CTD submissions and review of promotional materials is a plus.

Aufgaben

• Lead the submission strategy for marketing authorization of new medicinal products.
• Oversee lifecycle management of currently registered products.
• Ensure regulatory tasks comply with external and internal regulations, guidelines and legal bases.
• Coordinate with authorities and internal/external SMEs for efficient collaboration.

Kenntnisse

Regulatory affairs experience

Analytical mindset

Independent working

Team collaboration

Stakeholder management

German language

English language

Ausbildung

University degree in pharmacy, medicine or natural sciences

Jobbeschreibung

Merck Healthcare in Zug is seeking a Regulatory Affairs Manager on a fixed-term basis to support the maternity leave covering 1 January 2027 to 31 March 2028. You will lead regulatory submissions strategy for new medicinal products and lifecycle management while ensuring compliance with local laws and guidelines.

The role requires collaboration with Head Regulatory Affairs, global teams, and authorities, with deep focus on promotional material review and regulatory strategy.