Clinical Trial Application Lead, Biogen West Coast Hub

Biogen

San Francisco, CA, United States
Base: $118,000.00-$158,000.00; bonus/equity: cash ...
Hybrid
Clinical trial application activities
Eu ctr requirements
Cro collaboration
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

Job Summary

  • 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.
  • This is a hybrid role based in the SF Bay Area and will support high-priority clinical programs in Biogen’s immunology portfolio.
  • Biogen offers a full and highly competitive range of benefits designed to support employees’ and their families physical, financial, emotional, and social well-being.

Matching Summary

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.

Salary

Base: $118,000.00-$158,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurances, Fitness & Wellness programs, Disability insurance, Paid time off, Holidays, Paid Maternity and Parental Leave, 401(k) with match, ESPP, Tuition reimbursement

Skills & Requirements

Must-have

  • Clinical trial application activities
  • EU CTR requirements
  • CRO collaboration
  • Regulatory submission packages
  • Query management

Nice-to-have

  • Proactive and detailed-oriented
  • Collaborative mindset
  • Strategic thinking and risk assessment
  • Process enhancement

Key Requirements

  • Bachelor’s degree in life sciences or related field
  • 5+ years of experience in clinical trial startup
  • 5+ years of experience in regulatory affairs
  • Experience with EU CTR requirements
  • Familiarity with CRO operations

Work Rights

Not specified

Tailored Resume

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