Clinical Trial Application Lead, Biogen West Coast Hub

Role Summary

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.

Responsibilities

• 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 finalization and submission of responses to competent authorities.
• Track and coordinate responses to regulatory and deficiency letters with subject matter experts.
• Monitor and report on CTA status and updates and study startup progress across assigned projects.
• Maintain internal regulatory files and ensure documentation is complete and accessible, compliant with ICH-GCP, local regulations and internal processes.
• Support audits and inspections related to clinical trial applications.

Qualifications

• Required: Bachelor’s degree in life sciences or related field.
• Required: 5+ years of experience in clinical trial startup and regulatory affairs within the pharmaceutical or biotech industry.
• Required: Experience with compiling and reviewing regulatory submissions, particularly in accordance with the requirements of EU CTR.
• Required: Familiarity with CRO operations and global regulatory requirements for clinical trial applications.
• Required: Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Preferred: Effective communication and interpersonal skills; ability to work collaboratively across teams.
• Preferred: Capable of strategic thinking and risk assessment related to clinical trials.
• Preferred: Proficient in project management and documentation systems.

Education

• Advanced degree preferred.