Clinical Trial Application Lead, West Coast Hub

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.

• 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.

You are a proactive and detail-oriented individual who thrives in a dynamic environment. Your commitment to patient outcomes 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.

• 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.

• 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.

The base compensation range for this role is: $-$

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• 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

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.