Global Regulatory Lead, Immunology Expansion, WCH

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.
  • 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.
• 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, strategic thinking, and regulatory innovation within the function.

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.
• Thrive in fast-paced, high-growth environments requiring enterprise-level thinking and hands-on leadership.