Responsibilities Serve as Global Regulatory Lead (GRL) for early and late-stage West Coast Hub (WCH) programs; own global regulatory strategy across the full product lifecycle (early development through registration, post-approval, and indication expansion). Own and continuously evolve the global regulatory strategy as programs advance, increase in complexity, and expand across indications and geographies. Provide WCH portfolio-level regulatory leadership (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. Provide scientific and regulatory guidance and serve as a recognized technical expert/thought leader. Lead complex cross-functional regulatory workstreams (Clinical Development, PO&T, Clinical Operations, Pharmacovigilance, Medical Affairs, Commercial, and external partners). Lead and negotiate high-impact interactions with global health authorities (e.g., FDA, EMA, PMDA) including milestone/advisory engagements and alignment on development/registration plans. Make decisions impacting departmental and enterprise objectives, results, reputation, and regulatory risk; contribute to portfolio planning and go/no-go decisions. Mentor and lead regulatory team members; support scaling/maturation of the Regulatory function and establish best-in-class regulatory frameworks. Qualifications & 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 submissions (NDA, BLA, MAA). Proven experience owning global regulatory strategy across early- to 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/regulatory topics into clear business strategies and decision frameworks. Thrives in fast-paced, high-growth environments with enterprise-level thinking and hands‑on leadership. Benefits Medical, Dental, Vision & Life insurance Fitness & Wellness (fitness reimbursement) Short- and Long-Term Disability Paid vacation (minimum 15 days) plus end‑of‑year shutdown (Dec 26–Dec 31) Up to 12 paid holidays + 3 personal days Sick time (80 hours/year) Paid Maternity and Parental Leave 401(k) with company match Employee stock purchase plan Tuition reimbursement (up to $10,000/year) Employee Resource Groups participation #J-18808-Ljbffr