Global Regulatory Lead, Immunology Expansion, WCH

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.* 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.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.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.* 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.* 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.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.Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.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. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families *physical, financial, emotional,* and *social well-being*; including, but not limited to:* Medical, Dental, Vision, & Life insurances* Fitness & Wellness programs including a fitness reimbursement* Short- and Long-Term Disability insurance* A 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 participationWe are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

to learn more about our DE&I efforts.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.We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.## **Caring Deeply. Achieving Excellence. Changing Lives.****Scam Advisory:**

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