Director, Regulatory Affairs – Strategy

🕒 Agosto 12

☕ Washington – Remoto

☕ Washington – Remote

💵 $220.000 - $260.000 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

👻 Score fantasma 13%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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LeonaBio

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

🏥 Saúde

💰 $103.500.000 Post IPO equity em 2021-02

Biotechnology • Pharmaceuticals • Healthcare

A LeonaBio é uma empresa biofarmacêutica em estágio clínico que se concentra no desenvolvimento de novas terapias de pequenas moléculas para doenças graves com opções de tratamento limitadas. Seus principais candidatos incluem o lasofoxifeno e o brelgometon (ATH-1105), e a empresa realiza ensaios clínicos para avaliar a segurança e eficácia como parte de sua missão de melhorar o cuidado ao paciente. A LeonaBio está ativa em assuntos médicos e engajamento de pacientes e recentemente apresentou o ATH-1105 em um congresso de desenvolvimento de medicamentos para ELA, indicando envolvimento na pesquisa de doenças neurodegenerativas.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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