Senior Associate, Clinical Trials Regulatory Affairs

Amgen SA; Rotkreuz; Hybrid; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Amgen SA in Switzerland seeks a Senior Associate Regulatory Affairs to perform regulatory submissions to Swissmedic for clinical trials, compile dossiers, and drive regulatory activities in line with local regulations and Amgen policies.

The role requires strong English and German, Master or Bachelor in natural sciences, and the ability to manage timelines and collaborate with global teams across time zones.

Qualifikationen

• Experience with regulatory submissions in Switzerland (Swissmedic) or biotech/pharma CRO environments.
• Proven study start-up experience and ability to manage regulatory timelines.
• Excellent written and verbal communication in English; fluent German.
• Ability to plan, develop, and manage timelines and multiple projects.
• Strong relationships with health authorities and cross-functional teams.

Aufgaben

• Perform regulatory submissions in Switzerland to Swissmedic and compile submission dossiers.
• Coordinate regulatory activities for clinical trial projects per local regulations and Amgen policy.
• Interact with Clinical Project Management, Global Study Operations, and Regulatory teams.
• Maintain regulatory databases and checklists and update timelines.
• Escalate issues to leadership and mitigate risks.

Kenntnisse

Regulatory submissions

Swissmedic

Study start-up experience

Timeline management

Cross-functional collaboration

English and German fluency

Ausbildung

Master’s degree in natural sciences

Bachelor’s degree in natural sciences

Jobbeschreibung

Amgen SA in Switzerland seeks a Senior Associate Regulatory Affairs to perform regulatory submissions to Swissmedic for clinical trials, compile dossiers, and drive regulatory activities in line with local regulations and Amgen policies.

The role requires strong English and German, Master or Bachelor in natural sciences, and the ability to manage timelines and collaborate with global teams across time zones.