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 escalate 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 submission, 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.
