Global Regulatory Lead, Immunology Expansion, WCH

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/no ‑ 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, str

Benefits

Additional Information

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. This is a highly visible, enterprise ‑ level leadership role that requires deep regulatory expertise, scientific and strategic thought leadership, and the ability to influence decision ‑ making across senior leadership, global functions, and external stakeholders. The Senior Director will be recognized internally and externally as a regulatory and scientific leader who shapes development strategy, drives portfolio ‑ level outcomes, and enhances the organization's scientific and regulatory reputation.

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