Director, Regulatory Affairs, Strategy

AboutLeonaBio

LeonaBio, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for high unmet medical needs, including amyotrophic lateral sclerosis (ALS) and treatment-resistant metastatic breast cancer, with the goal of improving patients' lives. Our lead drug candidates, lasofoxifene and ATH-1105, are novel, small molecule therapies with the potential to address devastating diseases where current treatment options are limited or ineffective. With a strong commitment to scientific excellence and patient-centered innovation, we are dedicated to developing meaningful new therapies for those who need them most.

Position Summary

LeonaBio is seeking a Director, Regulatory Affairs, Strategy to lead global regulatory strategy across two development programs — one advancing toward a US and EU marketing application, and one moving into late-phase development. Reporting to the VP, Regulatory Affairs, this is a hands‑on strategist role with significant autonomy and the opportunity to shape regulatory strategy across the organization. The successful candidate will serve as a trusted partner, identifying opportunities and risks early, developing well‑reasoned options, and providing clear, actionable recommendations to support program and business decisions. This is a unique opportunity to influence critical development and registration strategies at a pivotal stage for both programs, with direct exposure to executive leadership. The ideal candidate combines deep regulatory expertise with strong strategic thinking, sound judgment, and the ability to influence cross‑functional decision‑making in a fast‑paced development environment.

Key Responsibilities

• Own global regulatory strategy for both programs — target product profile, labeling, filing sequence, and expedited‑pathway strategy — translated into a dated plan aligned with clinical, CMC, and program timelines. Own the regulatory critical path and elevate risks with recommended options.

• Lead US marketing application readiness — gap assessments, module ownership, content plan, submission timeline — through submission‑level authoring and sign‑off, managing the review period end to end. Plan post‑approval lifecycle management, including commitments, supplements, and labeling changes.

• Own health authority strategy and execution across both programs, from pre‑NDA meetings through Type B/C/D meetings and EMA Scientific Advice, including briefing packages, question strategy, and rehearsal.

• Anticipate regulatory risks, questions, and objections, and develop proactive strategies, evidence based positions, and contingency approaches to support successful health authority interactions and program outcomes.

• Develop regulatory strategies and health authority engagement plans that incorporate primary objectives, alternative approaches, and contingency options to maximize the likelihood of successful outcomes.

• Lead the regulatory work to move the early‑phase program into late‑phase development, including the health authority interaction sequence needed to reach agreement on a registration‑enabling design.

• Serve as the Company's primary point of contact with FDA and manage ex‑US interactions through regional consultants and partners. Actively manage consultants and vendors on scope, quality, and timeline.

• Influence cross‑functional decisions by integrating regulatory considerations into clinical development, translational science, biostatistics, pharmacovigilance, regulatory operations, medical affairs, and CMC planning.

• Represent Regulatory Affairs on program teams and governance forums, and review regulatory content in protocols, investigator brochures, and clinical study reports.

• Translate complex regulatory requirements, emerging regulatory intelligence, and health authority feedback into clear, actionable recommendations for technical teams, program leaders, and executive management.

• Build the function's core infrastructure — submission standards, health authority process, regulatory intelligence — and maintain compliance with ICH guidance and internal SOPs.

• Operate within a lean, cross‑functional team; no direct reports at hire, though the role may grow a small team over time. Approximately 10‑15% travel, with flexibility for West Coast time zone.
  

Required Qualifications

• Advanced degree in a life science discipline (PharmD, PhD, MD, MS) preferred. 8+ years of experience in biopharmaceutical regulatory affairs, including 5+ years in global regulatory strategy; candidates with a higher level of education may be considered with fewer years of experience.

• Demonstrated ownership of at least one US marketing application (NDA or BLA) or major US/EU sub‑mission, from readiness through submission and ideally approval.

• Direct experience leading FDA meetings as the regulatory lead, including briefing authorship and a speaking role.

• Experience carrying a program from early into late‑phase development, including reaching agreement with a health authority on a registration‑enabling design.

• Working knowledge of ex‑US requirements (EU CTR/CTIS, MAA, Scientific Advice) and familiarity with at least one other major region.

• Excellent scientific writing and speaking skills, and sound judgment under incomplete information.

• Demonstrated ability to leverage AI‑enabled tools and emerging technologies to enhance regulatory strategy development, regulatory intelligence, document authoring, data analysis, and operational efficiency, while ensuring appropriate scientific rigor, critical thinking, and regulatory compliance.

• Demonstrated ability to develop, defend, and adapt regulatory strategy in situations where regulatory precedent is limited, evolving, or subject to interpretation.

• Proven ability to influence cross‑functional teams, build alignment among diverse stakeholders, and drive decision‑making without direct authority.

• Experience balancing regulatory, scientific, operational, and benefit‑risk considerations when developing strategic recommendations for development and registration programs.

Preferred Qualifications

• Experience in oncology and/or in neurology, neurodegenerative, or rare disease development.

• Expedited program experience: Fast Track, Breakthrough Therapy, orphan drug designation, accelerated approval, or PRIME.

• Companion diagnostic or drug‑device co‑development experience.

• Sufficient regulatory CMC literacy to partner effectively with a dedicated CMC regulatory counterpart.

• Experience operating in a lean biotechnology environment where strategic leadership, independent decision‑making, and hands‑on execution are equally important.

LeonaBioisanequalopportunityemployeranddoesnotunlawfullydiscriminateagainstemployeesorapplicantsforemploymentonthebasisofanindividual’srace,color,religion,creed,sex,nationalorigin,age,disability,maritalstatus,veteranstatusoranyotherstatusprotectedbyapplicablelaw.Thispolicyappliestoallterms,conditionsandprivilegesofemployment,includingrecruitment,hiring,placement,compensation,promotion,disciplineandtermination.