Senior Principal, Regulatory Strategy

🕒 Outubro 22

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 10%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 19 dias.
• As vagas desta empresa costumam ser preenchidas em 37 dias.
• Sem salário divulgado.

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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

• Deliver high-impact regulatory strategies for C-level and function-head client executives • Partner with the SVP & Practice Lead to execute Lumanity's Clinical & Regulatory practice strategy • Maintain direct accountability for client delivery, business development, and team growth and mentorship • Advise pharmaceutical and biotech C-suite executives and function heads on critical development, program-level, and portfolio-focused decisions • Provide regulatory guidance on complex development programs, including novel modalities • Collaborate with other Lumanity practices to deliver integrated solutions addressing approval and access challenges • Generate new business, meet individual sales targets, and secure business with net-new clients • Lead pursuit strategies for complex regulatory engagements and support practice business development • Develop multi-year account strategies for key relationships • Provide strategic oversight across engagements and proactively manage risk and delivery quality • Mentor Lumanity team members and carry direct reports as needed • Champion collaboration and knowledge sharing across markets • Represent Lumanity at industry forums and regulatory conferences • Monitor the regulatory competitive landscape and share insights • Translate regulatory landscape changes into practice growth opportunities • Develop regulatory points of view and thought leadership • Contribute to consulting methodologies and develop new service offerings

🎯 Requisitos

• Minimum 15+ years progressive regulatory experience • Demonstrated success in both consulting environments and in-house biopharma regulatory roles • Direct experience leading regulatory strategies for development programs across multiple stages and therapeutic areas and/or product types • Demonstrated success contributing to or managing regulatory workstreams, projects, and teams • Proven ability to serve as a trusted advisor to pharmaceutical/biotech function heads and C-suite executives • Strong expertise across pre-IND through post-market/access regulatory activities, including designations, accelerated approval pathways, and complex regulatory strategies • 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 working knowledge of global regulatory harmonization • Deep regulatory expertise in 1+ major therapeutic area (oncology, CNS, rare disease, immunology, etc.) • Working knowledge and comfort working across other therapeutic areas • Experience across multiple product types, including small molecules, biologics, cell/gene therapies, and/or combination products • PhD, MPH, or MS in life sciences, regulatory affairs, or related field • Demonstrated ability to generate business and meet individual sales/revenue targets, with experience managing engagement-level budgets • Experience contributing to the development of new service offerings or capabilities within regulatory consulting • Active engagement in regulatory thought leadership, speaking engagements, and/or recognition as a subject-matter expert within one's professional network

🏖️ 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 • Professional development • Healthy work/life balance

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