Senior Director, European Regulatory Strategy Lead

🔥 2 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🧐 Strategy

👻 Ghost score 10%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Serve as European Regulatory Lead for cleminorexton and other assigned development programs • Develop and execute regulatory strategies 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 filings • Represent the company in meetings and interactions with the EMA, EU National Competent Authorities, MHRA, Swissmedic, and other health authorities • 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 capabilities and operational excellence • Identify, engage, and oversee external EU regulatory consultants and vendors • Collaborate with global regulatory colleagues to align European and other regional strategies

🎯 Requirements

• 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 • 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 • Strong 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 • Proven analytical, problem-solving, organizational, negotiation, and decision-making skills • Ability to thrive in a fast-paced, innovative environment • Advanced degree (PhD, PharmD, MS, or JD) and small molecule development experience 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

🏖️ Benefits

• Occasional travel including to the US • Equal opportunity and disability accommodation support during the application process

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