Clinical Trial Application Lead, Biogen West Coast Hub

The Clinical Trial Application Lead will support planning and execution of clinical trial application activities across global studies, collaborating with CROs and internal stakeholders to ensure timely and compliant study startup and maintenance. Experience with CTAs and EU CTR requirements is required. This hybrid role is based in the SF Bay Area and supports Biogen West Coast Hub immunology programs within Global Regulatory Affairs.

• Coordinate and implement study start up activities in collaboration with CROs and internal study teams.
• Assist in identifying country-specific regulatory requirements to facilitate timely CTA approvals.
• Participate in Study Management Team (SMT) meetings to provide regulatory guidance throughout the clinical trial lifecycle.
• Review and prepare submission packages for Regulatory Authorities for completeness and accuracy.
• Lead query management and the finalizatio...