Global Regulatory Lead, Immunology Expansion
Biogen, San Francisco, CA, United States
Role Overview
We are seeking a Senior Director, Regulatory Affairs to serve as the global regulatory strategy owner across both mid/late‑stage development and expanding early‑stage pipeline assets at Biogen’s West Coast Hub (WCH). This individual will be accountable for end‑to‑end global regulatory strategy, guiding programs from early development through registration, lifecycle management, and expansion into additional indications and geographies.
Key Responsibilities Global Regulatory Leadership & Strategy
Serve as Global Regulatory Lead (GRL) for early and late‑stage WCH programs, with accountability for global regulatory strategy across the full product lifecycle – from early development through registration, post‑approval, and indication expansion.
Own and continuously evolve the global regulatory strategy as programs advance from early to late stage, scale in complexity, and broaden in indications and geographic scope.
Provide strategic regulatory leadership at the WCH portfolio level, informing development sequencing, indication prioritization, and long‑term regulatory positioning.
Recommend expansion, modification, or curtailment of development strategies based on scientific evidence, regulatory intelligence, and evolving health authority expectations.
Scientific, Technical & Thought Leadership
Recognized as a leader within the function who provides scientific and regulatory guidance to a broad range of professionals and people managers.
Recognized internally and externally as a technical expert and thought leader in regulatory affairs, with influence on the direction of the organization’s scientific and development endeavors.
Contribute to the organization’s differentiation in the market through successful, timely advancement of novel programs, technologies, and regulatory strategies.
Maintain a high level of contribution to the discipline through publications, presentations, and external scientific or regulatory forums, enhancing the company’s scientific image and credibility.
Cross‑Functional & Enterprise Influence
Act as the senior regulatory representative on highly visible, multidisciplinary global program teams, leading initiatives that represent significant investment of resources and directly impact long‑term enterprise results.
Use leading‑edge and broad regulatory knowledge to lead complex, cross‑functional workstreams involving Clinical Development, PO&T, Clinical Operations, Pharmacovigilance, Medical Affairs, Commercial, and external partners.
Provide solutions and novel regulatory methodologies to complex, ambiguous issues through highly conceptual thinking and broad scientific insight.
Influence senior leadership decision‑making, identify multiple strategic options, and recommend a clear course of action in complex, high‑stakes situations.
Health Authority Engagement & External Representation
Lead and negotiate high‑impact interactions with global health authorities (FDA, EMA, PMDA, and others), including strategy for milestone meetings, advisory engagements, and alignment on development and registration plans.
Enhance the organization’s scientific and regulatory reputation through public representation of externally visible innovations, regulatory advancements, and successful development outcomes.
Engage with senior management, regulators, and external partners to influence decisions critical to long‑term program and portfolio success.
Decision Impact, Resource Stewardship & Business Outcomes
Make decisions that directly impact the objectives, long‑term results, and reputation of the department, development organization, and broader enterprise.
Influence and inform resource allocation decisions across the WCH Regulatory function, with a demonstrated track record of innovative regulatory strategies that have materially impacted the business.
Contribute to portfolio planning, regulatory risk assessment, and go
o‑go decision‑making at the program and enterprise level.
People Leadership & Function Building
Provide senior‑level mentorship and leadership to regulatory team members across the Biogen enterprise, fostering development of future leaders and promoting regulatory excellence.
Support scaling and maturation of the Regulatory function, including hiring, onboarding, capability development, and establishment of best‑in‑class regulatory frameworks suitable for a growing organization.
Create a culture of scientific rigor, strategic thinking, and regulatory innovation within the function.
Education and Experience
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.
Required Skills
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.
Job Level: Management
Compensation and Benefits The base compensation range for this role is: $246,000.00-$338,000.00. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
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
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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Key Responsibilities Global Regulatory Leadership & Strategy
Serve as Global Regulatory Lead (GRL) for early and late‑stage WCH programs, with accountability for global regulatory strategy across the full product lifecycle – from early development through registration, post‑approval, and indication expansion.
Own and continuously evolve the global regulatory strategy as programs advance from early to late stage, scale in complexity, and broaden in indications and geographic scope.
Provide strategic regulatory leadership at the WCH portfolio level, informing development sequencing, indication prioritization, and long‑term regulatory positioning.
Recommend expansion, modification, or curtailment of development strategies based on scientific evidence, regulatory intelligence, and evolving health authority expectations.
Scientific, Technical & Thought Leadership
Recognized as a leader within the function who provides scientific and regulatory guidance to a broad range of professionals and people managers.
Recognized internally and externally as a technical expert and thought leader in regulatory affairs, with influence on the direction of the organization’s scientific and development endeavors.
Contribute to the organization’s differentiation in the market through successful, timely advancement of novel programs, technologies, and regulatory strategies.
Maintain a high level of contribution to the discipline through publications, presentations, and external scientific or regulatory forums, enhancing the company’s scientific image and credibility.
Cross‑Functional & Enterprise Influence
Act as the senior regulatory representative on highly visible, multidisciplinary global program teams, leading initiatives that represent significant investment of resources and directly impact long‑term enterprise results.
Use leading‑edge and broad regulatory knowledge to lead complex, cross‑functional workstreams involving Clinical Development, PO&T, Clinical Operations, Pharmacovigilance, Medical Affairs, Commercial, and external partners.
Provide solutions and novel regulatory methodologies to complex, ambiguous issues through highly conceptual thinking and broad scientific insight.
Influence senior leadership decision‑making, identify multiple strategic options, and recommend a clear course of action in complex, high‑stakes situations.
Health Authority Engagement & External Representation
Lead and negotiate high‑impact interactions with global health authorities (FDA, EMA, PMDA, and others), including strategy for milestone meetings, advisory engagements, and alignment on development and registration plans.
Enhance the organization’s scientific and regulatory reputation through public representation of externally visible innovations, regulatory advancements, and successful development outcomes.
Engage with senior management, regulators, and external partners to influence decisions critical to long‑term program and portfolio success.
Decision Impact, Resource Stewardship & Business Outcomes
Make decisions that directly impact the objectives, long‑term results, and reputation of the department, development organization, and broader enterprise.
Influence and inform resource allocation decisions across the WCH Regulatory function, with a demonstrated track record of innovative regulatory strategies that have materially impacted the business.
Contribute to portfolio planning, regulatory risk assessment, and go
o‑go decision‑making at the program and enterprise level.
People Leadership & Function Building
Provide senior‑level mentorship and leadership to regulatory team members across the Biogen enterprise, fostering development of future leaders and promoting regulatory excellence.
Support scaling and maturation of the Regulatory function, including hiring, onboarding, capability development, and establishment of best‑in‑class regulatory frameworks suitable for a growing organization.
Create a culture of scientific rigor, strategic thinking, and regulatory innovation within the function.
Education and Experience
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.
Required Skills
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.
Job Level: Management
Compensation and Benefits The base compensation range for this role is: $246,000.00-$338,000.00. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
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
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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