Hybrid Global Regulatory Lead, Immunology Expansion

at Biogen

• Job title: Global Regulatory Lead, Immunology Expansion
• Job type: Full Time
• Experience level: Senior
• Salary: $246,000 - $338,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, San Francisco, United States

About the role

• Senior Director of Regulatory Affairs at Biogen responsible for global regulatory strategy across biopharmaceutical products. Providing leadership in regulatory submissions and interactions with health authorities.

Responsibilities

• Serve as Global Regulatory Lead (GRL) for early and late ‑ stage WCH programs, with accountability for global regulatory strategy across the full product lifecycle
• Own and continuously evolve the global regulatory strategy as programs advance
• Provide strategic regulatory leadership at the WCH portfolio level
• Recommend expansion, modification, or curtailment of development strategies based on scientific evidence
• Recognized internally and externally as a technical expert and thought leader in regulatory affairs
• Act as the senior regulatory representative on highly visible, multidisciplinary global program teams
• Lead and negotiate high ‑ impact interactions with global health authorities
• Make decisions that directly impact the objectives, long ‑ term results, and reputation of the department
• Provide senior ‑ level mentorship and leadership to regulatory team members

Requirements

• Bachelor’s degree; advanced degree (PhD, PharmD, MS, MD, or related life ‑ science discipline) preferred
• 15+ years of progressive Regulatory Affairs experience in the biopharmaceutical industry
• Demonstrated success as a Global Regulatory Lead on late ‑ stage programs, including major global submissions (e.g., NDA, BLA, MAA)
• Proven experience owning global regulatory strategy across early ‑ stage through late ‑ stage development, including lifecycle management and indication expansion.
• Deep understanding of global clinical, registration, and post ‑ approval regulatory requirements.
• Strong record of strategic influence, executive ‑ level communication, and cross ‑ functional leadership.
• Ability to translate complex scientific and regulatory topics into clear business strategies and decision frameworks.
• Thrives in fast ‑ paced, high ‑ growth environments requiring enterprise ‑ level thinking and hands ‑ on leadership.

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