Senior Associate Clinical Trials Regulatory Affairs

About the role

Amgen is seeking a Senior Associate to lead regulatory submissions for clinical trials in Switzerland. You will work closely with cross‑functional teams to ensure compliance with Swissmedic requirements and Amgen’s internal policies.

Key responsibilities

• Prepare and submit initial applications, protocol amendments, ICF amendments, CMC amendments and periodic reports to Swissmedic.
• Act as the primary local contact with Swissmedic, maintaining regulatory timelines and status updates.
• Collaborate with Clinical Project Management, Global Regulatory, CMC, and Pharmacovigilance teams to align on requirements.
• Maintain the regulatory database and checklists, and communicate milestones to internal and external partners.

Required profile

• Master’s or Bachelor’s degree in natural sciences.
• Experience with regulatory submissions for clinical trials in Switzerland or similar biotech/pharma environment.
• Fluent in English and German, with strong written and verbal communication skills.
• Ability to manage multiple projects, work independently and across time zones.

Required skills

• Regulatory submissions
• Clinical trial applications
• Swissmedic processes