Senior Associate Clinical Trials Regulatory Affairs

The Senior Associate Clinical Trials Regulatory Affairs role at Amgen involves leading the preparation and submission of regulatory dossiers for early-phase oncology programs. This includes managing IND, CTA, and BLA submissions, coordinating cross-functional review cycles, and interacting with Swissmedic and European regulatory bodies to ensure timely approvals. The main responsibilities include drafting high-quality regulatory documents and managing multiple projects under tight deadlines. The role requires strong knowledge of EU and Swiss clinical trial legislation and the ability to work in a matrix environment. The ideal candidate must have at least 4 years of experience in pharmaceutical regulatory affairs, excellent communication skills in English, and a detail-oriented mindset. Proficiency in German is a plus. What the role asks for: - 4 years of experience in pharmaceutical regulatory affairs - Strong knowledge of EU and Swiss clinical trial legislation - Excellent communication skills in English - Detail-oriented mindset - Experience working in a matrix environment - Proficiency in German (nice to have)