Director, Regulatory Affairs – Strategy

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🔥 0 minutes ago

☕ Washington – Remote

☕ Washington – Remote

💵 $220k - $260k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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LeonaBio

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $103.5M Post IPO equity on 2021-02

Biotechnology • Pharmaceuticals • Healthcare

LeonaBio is a clinical-stage biopharmaceutical company focused on developing novel small-molecule therapies for serious diseases with limited treatment options. Its lead candidates include lasofoxifene and brelgometon (ATH-1105), and the company conducts clinical trials to evaluate safety and efficacy as part of its mission to improve patient care. LeonaBio is active in medical affairs and patient outreach and has recently presented ATH-1105 at an ALS drug development summit, indicating involvement in neurodegenerative disease research.

📋 Description

• Own global regulatory strategy for both development programs, including target product profile, labeling, filing sequence, and expedited-pathway strategy • Translate regulatory strategy into dated plans aligned with clinical, CMC, and program timelines • Own the regulatory critical path and escalate risks with recommended options • Lead US marketing application readiness through submission-level authoring, sign-off, and end-to-end review-period management • Plan post-approval lifecycle management, including commitments, supplements, and labeling changes • Own health authority strategy and execution across FDA and EMA interactions, including briefing packages, question strategy, and rehearsal • Anticipate regulatory risks, questions, and objections and develop proactive, evidence-based, and contingency strategies • Lead regulatory work to move the early-phase program into late-phase development and reach agreement on a registration-enabling design • Serve as the primary company contact with FDA and manage ex-US interactions through regional consultants and partners • Manage consultants and vendors on scope, quality, and timeline • Integrate 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 • Translate regulatory requirements, intelligence, and health authority feedback into actionable recommendations • Build submission standards, health authority processes, and regulatory intelligence infrastructure • Maintain compliance with ICH guidance and internal SOPs • Operate within a lean, cross-functional team with no direct reports at hire

🎯 Requirements

• 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 • Ability to leverage AI-enabled tools and emerging technologies for regulatory strategy, intelligence, authoring, data analysis, and operational efficiency while ensuring scientific rigor and compliance • Ability to develop, defend, and adapt regulatory strategy where precedent is limited, evolving, or subject to interpretation • Ability to influence cross-functional teams, build stakeholder alignment, and drive decisions without direct authority • Experience balancing regulatory, scientific, operational, and benefit-risk considerations • Experience in oncology and/or neurology, neurodegenerative, or rare disease development preferred • Expedited program experience preferred: Fast Track, Breakthrough Therapy, orphan drug designation, accelerated approval, or PRIME • Companion diagnostic or drug-device co-development experience preferred • Sufficient regulatory CMC literacy to partner with a dedicated CMC regulatory counterpart • Experience in a lean biotechnology environment where strategic leadership, independent decision-making, and hands-on execution are important

🏖️ Benefits

• Approximately 10–15% travel • Flexibility for West Coast time zone • Significant autonomy and direct exposure to executive leadership • Opportunity to shape regulatory strategy across the organization • Potential to grow a small team over time