Job Details

As the Regulatory Manager, Clinical Trial Application (CTA) Lead, you will play a key role in supporting the planning and execution of clinical trial application activities across global studies. You will collaborate closely with Clinical Research Organizations (CROs) and internal stakeholders such as study management teams to ensure timely and compliant study startup and maintenance. You must have experience with clinical trial applications, particularly in the EU to be successful in this role. The Regulatory Manager will report to the Head of Clinical Trials Application, within Biogens Global Regulatory Affairs organization. This is a hybrid role based in the SF Bay Area. As part of Biogens WCH, this role will support high-priority clinical programs in Biogens immunology portfolio. What You will Do:Coordinate and implement study start up activities in collaboration with CROs and internal study teams. Assist in identifying country-specific regulatory requirements to facilitate time...Clinical, Application, Clinical Research, Lead, Regulatory Affairs, Project Management, Manufacturing, Business Services