Clinical Trial Application Lead, Biogen West Coast Hub

About the position About This Role: 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 Biogen’s Global Regulatory Affairs organization. This is a hybrid role based in the SF Bay Area. As part of Biogen’s WCH, this role will support high-priority clinical programs in Biogen’s 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 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. Who You Are: You are a proactive and detailed-oriented individual who thrives in a dynamic environment. Your commitment to patient outcome drives your ability to manage clinical trial applications with finesse and ensure accurate submissions and smooth approvals. Your ability to coordinate regulatory documents for submissions showcases your organizational adaptability. You approach challenges with a collaborative mindset and constantly seek ways to enhance processes.

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.

Requirements

• 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.
• Experience with compiling and reviewing regulatory submissions, particularly in accordance with the requirements of EU CTR
• Familiarity with CRO operations and global regulatory requirements for clinical trial applications.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.

Nice-to-haves

• Advanced degree.
• Effective communication and interpersonal skills; ability to work collaboratively across teams.
• Capable of strategic thinking and risk assessment related to clinical trials.
• Proficient in project management and documentation systems.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

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