Senior Associate Clinical Trials Regulatory Affairs

Amgen is a global biotechnology leader focused on developing and delivering medicines that improve the lives of millions of patients. The Senior Associate Clinical Trials Regulatory Affairs position supports this mission by handling regulatory work for clinical studies conducted in Switzerland, ensuring that all submissions meet Swissmedic requirements and Amgen's internal policies. In this role you will prepare and file complete regulatory dossiers for new and ongoing trials, covering initial applications, protocol and informed‑consent amendments, CMC changes, periodic reports and study closure. You will act as the primary liaison with Swissmedic, keep internal teams informed of regulatory status, attend cross‑functional meetings to outline timelines, maintain a regulatory checklist database, and coordinate with study start‑up staff, vendors and contracts to meet milestone dates. When issues arise you will raise them to leadership and propose mitigation plans. The position requires a university degree, either a master's or a bachelor's, in a natural‑science discipline. You must have hands‑on experience preparing Swissmedic clinical trial submissions or comparable start‑up work within a biotech, pharmaceutical company or CRO. Strong written and spoken English skills and fluency in German are essential. You need to demonstrate the ability to create, update and track project timelines, juggle several priorities at once, and build constructive relationships with health authorities, colleagues and external service providers. Working independently and asynchronously across different time zones within a matrixed organization is also expected. Amgen offers a collaborative, inclusive environment where professional growth is encouraged through internal mobility and learning opportunities. The Swiss location provides a dynamic setting within a diverse team that values ideas and teamwork. Employees benefit from a comprehensive total‑rewards package that includes health, financial and work‑life‑balance components, reinforcing the company's commitment to both patient outcomes and employee well‑being. What the role asks for: - Master's or Bachelor's degree in natural sciences - Experience with Swissmedic clinical trial submissions - Experience in biotech/pharma or CRO clinical research - Excellent written and verbal English communication - Fluent German language proficiency - Proven ability to plan and manage timelines - Ability to handle multiple projects simultaneously - Strong relationship‑building with health authorities and stakeholders - Independent work across time zones in matrixed team