Senior Director, European Regulatory Strategy

🔥 2 hours ago

🇬🇧 United Kingdom – Remote

💵 $160.5k - $259.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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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 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

🎯 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 • 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

🏖️ Benefits

• 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