Global Regulatory Lead, Immunology Expansion, WCH
Biogen
June 26, 2026
Remote friendly (San Francisco, CA)
United States
Corporate Functions
Role Overview / Responsibilities
- Serve as Global Regulatory Lead (GRL) for early- and late-stage West Coast Hub programs; own global regulatory strategy across the full product lifecycle (early development through registration, post-approval, and indication expansion).
- Own and continuously evolve global regulatory strategy as programs advance; guide portfolio-level planning (development sequencing, indication prioritization, long-term positioning).
- Recommend expansion/modification/curtailment of development strategies based on scientific evidence, regulatory intelligence, and evolving health authority expectations.
- Provide scientific and regulatory thought leadership; guide professionals and people managers.
- Lead complex, cross-functional workstreams (Clinical Development, PO&T, Clinical Ops, Pharmacovigilance, Medical Affairs, Commercial, and external partners) and develop novel regulatory solutions/methodologies.
- Lead and negotiate high-impact interactions with global health authorities (FDA, EMA, PMDA, and others) for milestone/advisory engagement and alignment on development/registration plans.
- Make decisions impacting department/enterprise objectives, reputation, and regulatory risk; contribute to portfolio planning and go/no-go decisions.
- Provide senior mentorship; scale and mature the Regulatory function (hiring, onboarding, frameworks) and create a culture of rigor and regulatory innovation.
Qualifications
- Bachelor’s degree; advanced degree preferred (PhD, PharmD, MS, MD or related life science).
- 15+ years progressive Regulatory Affairs experience in biopharma.
Required Skills
- Demonstrated GRL success on late-stage programs with major submissions (NDA/BLA/MAA).
- Ownership of global regulatory strategy from early to late stage, including lifecycle management and indication expansion.
- Deep understanding of global clinical, registration, and post-approval requirements.
- Strategic influence, executive communication, cross-functional leadership; translate complex science/regulatory topics into business strategy.
Benefits (as stated)
- Medical, dental, vision, life; fitness & wellness reimbursement; short- and long-term disability; paid vacation and year-end shutdown; holidays/personal days; sick time; paid maternity/parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
- Serve as Global Regulatory Lead (GRL) for early- and late-stage West Coast Hub programs; own global regulatory strategy across the full product lifecycle (early development through registration, post-approval, and indication expansion).
- Own and continuously evolve global regulatory strategy as programs advance; guide portfolio-level planning (development sequencing, indication prioritization, long-term positioning).
- Recommend expansion/modification/curtailment of development strategies based on scientific evidence, regulatory intelligence, and evolving health authority expectations.
- Provide scientific and regulatory thought leadership; guide professionals and people managers.
- Lead complex, cross-functional workstreams (Clinical Development, PO&T, Clinical Ops, Pharmacovigilance, Medical Affairs, Commercial, and external partners) and develop novel regulatory solutions/methodologies.
- Lead and negotiate high-impact interactions with global health authorities (FDA, EMA, PMDA, and others) for milestone/advisory engagement and alignment on development/registration plans.
- Make decisions impacting department/enterprise objectives, reputation, and regulatory risk; contribute to portfolio planning and go/no-go decisions.
- Provide senior mentorship; scale and mature the Regulatory function (hiring, onboarding, frameworks) and create a culture of rigor and regulatory innovation.
Qualifications
- Bachelor’s degree; advanced degree preferred (PhD, PharmD, MS, MD or related life science).
- 15+ years progressive Regulatory Affairs experience in biopharma.
Required Skills
- Demonstrated GRL success on late-stage programs with major submissions (NDA/BLA/MAA).
- Ownership of global regulatory strategy from early to late stage, including lifecycle management and indication expansion.
- Deep understanding of global clinical, registration, and post-approval requirements.
- Strategic influence, executive communication, cross-functional leadership; translate complex science/regulatory topics into business strategy.
Benefits (as stated)
- Medical, dental, vision, life; fitness & wellness reimbursement; short- and long-term disability; paid vacation and year-end shutdown; holidays/personal days; sick time; paid maternity/parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.