Senior Associate Clinical Trials Regulatory Affairs

Career Category

Regulatory

Job Description

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.

SENIOR ASSOCIATE CLINICAL TRIALS REGULATORY AFFAIRS

LIVE

What you will do

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.

This position interacts directly with Clinical Project Management (Local Study Operations Managers), Global Study Operations, International Regulatory Team, CMC Global Product Leads, and Pharmacovigilance.

• Performs efficiently end-to-end Clinical Trials Regulatory submissions in the country for new and ongoing project(s) or programs, including and not limited to initial applications to Swissmedic, clinical protocol amendments, ICF amendments, quality (CMC) amendments, study periodic reporting, until the project is officially closed
• Acting as Amgen’s local contact with Swissmedic to fulfill regulatory obligations in alignment with global SOP and other supporting documentation.
• Seeks opportunities and standard methodologies with local and regional partners that will contribute to overall operational efficiency.
• Communicates overall regulatory status to internal teams and service providers.
• Attends to project meetings with cross functional department leads to provide regulatory timelines and requirements for regulatory submissions and approvals.
• Collaborates with internal team members to establish timelines and clarify regulatory requirements
• Maintains clinical trial regulatory requirements' database, including regular updates to checklists.
• Facilitates communication with the regional or local study team (e.g. Start-up Associates, Project Managers, Regulatory Affairs, Vendors, and Contracts Department) during the total duration of study, closely monitoring to ensure regulatory milestones are met.
• Escalates issues to leadership, including plans for addressing/mitigating risks/gaps.