Senior Director, European Regulatory Strategy

🕒 Outubro 12

🇬🇧 Reino Unido – Remoto (RU)

💵 $160.500 - $259.600 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 0%

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Eli Lilly and Company

SiteLinkedInTodas as Vagas

10.000+ funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

💰 $6.500.000 Post-IPO Debt - Eli Lilly em 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company é uma empresa farmacêutica multinacional que pesquisa, desenvolve, fabrica e comercializa medicamentos de prescrição em várias áreas terapêuticas, incluindo diabetes, oncologia, imunologia, neurociência e dor. Com sede em Indianápolis, Indiana, Lilly é conhecida por sua extensa P&D, desenvolvimento clínico e comercialização global de medicamentos biológicos e de pequenas moléculas. A empresa foca na descoberta de medicamentos, ensaios clínicos, aprovações regulatórias e fabricação e distribuição farmacêutica em larga escala.

Descrição

• Serve as the European Regulatory Lead for cleminorexton and other assigned development programs • Develop and execute regulatory strategies for product registrations across the European Union, United Kingdom, Switzerland, and other applicable regions • Lead planning, preparation, and submission of MAAs, CTAs, pediatric regulatory submissions, briefing documents, and other regulatory filings • Represent the company in meetings and interactions with European health authorities, including EMA, EU National Competent Authorities, MHRA, and Swissmedic • Provide EU regulatory guidance and strategic input to cross-functional program teams • Lead ex-US pediatric development and submission activities • Ensure compliance with European and international regulatory requirements and guidance • Communicate regulatory developments and implications to stakeholders • Partner with Regulatory Affairs leadership to strengthen departmental capabilities and operational excellence • Identify, engage, and oversee external EU regulatory consultants and vendors • Collaborate with global regulatory colleagues to align European strategies with other regional activities

🎯 Requisitos

• Bachelor's degree in a scientific discipline • 12+ years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry • 5+ years in a regulatory leadership role with significant European experience • Significant experience leading European regulatory strategies and submissions • Significant experience with EU pediatric regulatory strategy and submissions • Recent significant experience with EU regulatory submission strategy, structure, and content, including MAAs, CTAs, pediatric submissions, briefing documents, and other European regulatory filings • Track record of successful regulatory interactions with the EMA, EU National Competent Authorities, MHRA, Swissmedic, and other applicable health authorities • Experience serving as the European Regulatory Lead for development and registration-stage programs within a matrixed environment • Extensive knowledge of nonclinical and clinical drug development, ICH, EMA, EU regulatory requirements, EU National Competent Authorities, MHRA, Swissmedic, and other applicable international regulatory requirements and guidelines • Experience leading cross-functional teams and providing strategic regulatory guidance from early development through registration and lifecycle management • Excellent written, verbal, presentation, and influencing skills • Analytical, problem-solving, organizational, negotiation, and decision-making skills • Ability to thrive in a fast-paced, innovative environment while fostering collaboration, open communication, and stakeholder alignment • Advanced degree (PhD, PharmD, MS, or JD) and experience supporting small molecule development strongly preferred • CNS experience highly preferred • Experience with regulatory submissions and health authority interactions in Japan and/or China is a plus • Experience interfacing with a US-based Global Regulatory team and cross-functional partners

🏖️ Benefícios

• Company bonus, depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Certain time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities

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