Global Regulatory Lead, Immunology Expansion, Wch

Biogen

West Coast Hub, US
Base: $246,000.00-$338,000.00; bonus/equity: short...
15+ years progressive regulatory affairs experience
Global regulatory strategy ownership for late-stage programs
Experience with major global submissions (nda, bla, maa)
This enterprise-level leadership role is accountable for end-to-end global regulatory strategy across the full product lifecycle from early development through registration and expansion

Job Summary

  • This enterprise-level leadership role is accountable for end-to-end global regulatory strategy across the full product lifecycle from early development through registration and expansion.
  • The Senior Director will serve as a recognized thought leader, guiding complex cross-functional workstreams and negotiating high-impact interactions with global health authorities like the FDA and EMA.
  • Biogen offers a competitive compensation package including base salary up to $338,000, equity incentives, and comprehensive benefits such as tuition reimbursement and paid parental leave.

Matching Summary

This enterprise-level leadership role is accountable for end-to-end global regulatory strategy across the full product lifecycle from early development through registration and expansion.

Salary

Base: $246,000.00-$338,000.00; Bonus/Equity: Short-term cash bonus and long-term equity incentive opportunities available; Benefits: Medical, Dental, Vision, Life insurance, 401(k) match, Tuition reimbursement up to $10,000

Skills & Requirements

Must-have

  • 15+ years progressive Regulatory Affairs experience
  • Global regulatory strategy ownership for late-stage programs
  • Experience with major global submissions (NDA, BLA, MAA)
  • Deep understanding of FDA, EMA, PMDA requirements
  • Senior-level cross-functional leadership capabilities

Nice-to-have

  • Publications and external scientific forum presentations
  • Track record of innovative regulatory methodologies
  • Ability to influence senior leadership decision-making
  • Experience in early-stage pipeline asset development
  • Mentorship and team building skills

Key Requirements

  • Bachelor's degree required; advanced degree preferred
  • 15+ years of progressive Regulatory Affairs experience
  • Demonstrated success owning global regulatory strategy
  • Proven track record with NDA, BLA, or MAA submissions

Work Rights

Not specified

Tailored Resume

Cover Letter