Global Regulatory Lead, Immunology Expansion, WCH

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). The Senior Director 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. 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. 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 Provide scientific and regulatory guidance to a broad range of professionals and people managers. Maintain a high level of contribution to the discipline through publications, presentations, and external scientific or regulatory forums. Cross‑Functional & Enterprise Influence Act as the senior regulatory representative on highly visible, multidisciplinary global program teams. 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. Influence senior leadership decision‐making in high‑stakes situations. Health Authority Engagement & External Representation Lead and negotiate high‑impact interactions with global health authorities (FDA, EMA, PMDA, etc.). Engage with senior management, regulators, and external partners to influence critical decisions. Decision Impact, Resource Stewardship & Business Outcomes Make decisions that directly impact objectives, long‑term results, and reputation. Influence and inform resource allocation decisions across the WCH Regulatory function. Contribute to portfolio planning, regulatory risk assessment, and go/no‑go decision‑making. People Leadership & Function Building Provide senior‑level mentorship and leadership to regulatory team members across the Biogen enterprise. Support scaling and maturation of the Regulatory function, including hiring, onboarding, and capability development. 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. Benefits Competitive base salary range: $246,000 – $338,000. Short‑term and long‑term incentives, including cash bonus and equity opportunities. Comprehensive medical, dental, vision, and life insurance. Fitness and wellness programs with reimbursement. Short‑and long‑term disability insurance. 15 days paid vacation, additional end‑of‑year shutdown time off, 12 company paid holidays, and 3 paid personal significance days. 80 hours sick time per calendar year. Paid maternity and parental leave. 401(k) with company match. Employee stock purchase plan. Tuition reimbursement up to $10,000 per calendar year. Employee Resource Groups participation. Equal Employment Opportunity 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. #J-18808-Ljbffr