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.
• 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.
• Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being.

Matching Summary

Salary

Base: $118,000.00-$158,000.00; Bonus/Equity: short term and long-term incentives, cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, & Life insurances, Fitness & Wellness programs, Disability insurance, paid vacation, holidays, sick time, parental leave, 401(k), ESPP, tuition reimbursement

Skills & Requirements

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
• Global regulatory requirements for CTAs

Work Rights