Senior Associate Clinical Trials Regulatory Affairs

About the Position

Senior Associate Clinical Trials Regulatory Affairs

Switzerland - Rotkreuz

JOB ID: R-257337

LOCATION: Switzerland - Rotkreuz

WORK LOCATION TYPE: Flex Commuter / Hybrid

DATE POSTED: Oct. 13, 2026

CATEGORY: Regulatory

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If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

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Responsibilities

In this vital role as Senior Associate Clinical Trials Regulatory Affairs you will be responsible for:

• Performing Regulatory submissions in Switzerland to Swissmedic, compiling submission dossier, execution of all regulatory activities for clinical trial projects and programs, according to local regulations and Amgen’s policy.
• Acting as Amgen’s local contact with Swissmedic to fulfill regulatory obligations in alignment with global SOP and other supporting documentation.
• Seeking opportunities and standard methodologies with local and regional partners that will contribute to overall operational efficiency.
• Communicating overall regulatory status to internal teams and service providers.
• Attending to project meetings with cross-functional department leads to provide regulatory timelines and requirements for regulatory submissions and approvals.
• Collaborating with internal team members to establish timelines and clarify regulatory requirements.
• Maintaining clinical trial regulatory requirements' database, including regular updates to checklists.
• Facilitating communication with the regional or local study team during the total duration of study, closely monitoring to ensure regulatory milestones are met.
• Escalating issues to leadership, including plans for addressing/mitigating risks/gaps.

Requirements

• Master’s degree or Bachelor’s degree in natural sciences.
• Relevant experience with regulatory submissions and/or study start-up experience with technical knowledge performing Clinical Trial Applications in Switzerland (Swissmedic) or work experience in clinical research acquired while working on clinical trials for a biotech/pharma company or CRO.
• Excellent written and verbal communication skills in English as well as fluent in German.
• Ability to plan, develop, and manage timelines, including keeping them up to date.
• Comfortable managing multiple projects and priorities at the same time.
• Skilled at building and maintaining positive relationships with health authorities, colleagues, managers, and service providers.
• Able to work independently and asynchronously across time zones in a collaborative, matrixed team environment.

We Offer

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

About the Company

At Amgen, we are relentless in applying the highest ethical standards to our products, services, and communications. We expect all job applicants to act with honesty and integrity. Providing any false or misleading information, or omitting material information during the hiring process, may result in immediate disqualification from the hiring process or termination if already employed.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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Apply Now at Careers.Amgen.com.

Equal opportunity statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request an accommodation.