Vice President, Regulatory Strategy

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🕒 Maio 9

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Lumanity

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2020

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Lumanity está focada em melhorar a experiência do candidato por meio de soluções digitais modernas. As iniciativas da empresa incluem simplificar o processo de candidatura e utilizar dados anônimos para aprimorar a interação do usuário na plataforma. Eles enfatizam a privacidade e a conformidade em suas operações, garantindo que os dados dos candidatos sejam tratados com cuidado e transparência.

Descrição

• Acts as trusted strategic partner to pharmaceutical and biotech C-suite executives and other functional heads, influencing enterprise-wide regulatory strategies that extend across multiple development programs and corporate initiatives • Provides authoritative regulatory guidance on complex, multi-indication development programs, including novel modalities (cell/gene therapy, biologics, advanced therapeutics) • Partners with other Lumanity practices to deliver integrated solutions addressing interconnected regulatory, clinical, and quality challenges • Partners with SVP & Practice Lead to translate regulatory landscape changes (AI/digital submissions, global harmonization, policy evolution) into practice growth opportunities and competitive differentiation • Develops regulatory points of view that influence industry standards, shapes regulatory policy dialogue, and positions Lumanity as the authoritative voice in regulatory strategy consulting • Evolves consulting methodologies and develops new service offerings to address emerging regulatory challenges and client needs • Proactively supports the Clinical & Regulatory P&L, in collaboration with the SVP and Practice Lead, achieving annual revenue targets while maintaining target profitability margins • Dives personal and team BD performance, leading pursuit strategies for complex, high-value regulatory engagements while mentoring BD capability across the practice • Sets and reinforces delivery quality standards across regulatory team, ensuring consistency in regulatory strategy outputs while balancing profitability with client value • Shapes regulatory talent strategy through succession planning, mentorship of senior regulatory leaders, and development of next-generation regulatory capabilities • Champions collaboration and knowledge sharing across markets, accelerating reuse of regulatory frameworks and best practices • Represents Lumanity at senior industry forums and regulatory conferences building external credibility and market presence • Monitors regulatory competitive landscape and translates insights into practice positioning and service evolution

🎯 Requisitos

• Minimum 20+ years progressive regulatory experience with demonstrated success in both consulting environments and in-house biopharma regulatory leadership roles • Direct experience leading regulatory strategies for development programs throughout all stages and across different therapeutic areas and product types • Demonstrated success managing regulatory practices or teams • Proven ability to serve as trusted advisor to pharmaceutical/biotech VP-level and C-suite executives • Deep expertise across pre-IND through post-market regulatory activities, including designations, accelerated approval pathways, and complex regulatory strategies • Extensive experience leading Pre-IND meetings, Type C meetings, EOP2 discussions, and other critical regulatory interactions • International regulatory experience across major markets (EMA, Health Canada, PMDA) with understanding of global regulatory harmonization • Deep regulatory expertise in 2+ major therapeutic areas (oncology, CNS, rare disease, immunology, etc.) • Experience across multiple product types including small molecules, biologics, cell/gene therapies, and combination products • PhD, MPH, or MS in life sciences, regulatory affairs, or related field • MBA, RAC certification, or equivalent business/regulatory qualifications • Proven track record achieving annual revenue targets with demonstrated budget management experience • Success in opening new markets or service lines within regulatory consulting • Published regulatory thought leadership, speaking engagements, and recognition as regulatory industry authority

🏖️ Benefícios

• Competitive salary plus bonus scheme • Medical, dental, and vision insurance options • 401(k) plan with employer match • Flexible PTO • Flexible spending accounts for health and dependent care • Health savings account option with employer contribution • Employee Assistance Program • Paid short-term and long-term disability coverage and much more