Organization and Position Overview
As the Senior Director, European Regulatory Strategy, you will report to the SVP, Regulatory and Medical Writing and serve as a key member of our regulatory team, providing strategic and operational regulatory leadership across development programs with a primary focus on Europe.

Responsibilities

• Serve as the European Regulatory Lead for our lead program cleminorexton and other assigned development programs, providing strategic regulatory leadership from early development through registration and lifecycle management.
• Develop and execute regulatory strategies to obtain, maintain, and expand product registrations across the European Union, United Kingdom, Switzerland, and other applicable regions.
• Lead the planning, preparation, and submission of major regulatory filings, including Marketing Authorisation Applications (MAAs), Clinical Trial Applications (CTAs), pediatric regulatory submissions, briefing documents, and other regulatory submissions within scope of responsibility.
• Represent the company in regulatory interactions and lead meetings with European health authorities, including the EMA, EU National Competent Authorities, MHRA, and Swissmedic.
• Provide EU regulatory guidance and strategic input to cross-functional program teams, ensuring regulatory considerations are integrated into development plans and key business decisions.
• Provide strategic regulatory leadership for ex-US pediatric development and submission activities, including pediatric regulatory strategy, submission planning, and interactions with relevant health authorities.
• Ensure ongoing compliance with applicable European and international regulatory requirements and guidance, communicating regulatory developments and implications to relevant stakeholders.
• Partner with the SVP, Regulatory and Medical Writing and broader Regulatory Affairs leadership to strengthen departmental capabilities, operational excellence, and efficient execution across the portfolio.
• Identify, engage, and oversee external EU regulatory consultants and vendors to support the successful execution of regulatory strategies and submissions.
• Collaborate with global regulatory colleagues to ensure alignment between European regulatory strategies and development or registration activities in other regions, as appropriate.

Basic Requirements

• Bachelor's degree in a scientific discipline with 12+ years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry, including 5+ years in a regulatory leadership role with significant European experience.
• Advanced degree (PhD, PharmD, MS, or JD) and experience supporting small molecule development strongly preferred.
• Significant experience leading European regulatory strategies and submissions, including substantial experience with regulatory requirements and health authority interactions in the EU, UK, and/or Switzerland.
• Significant experience with EU pediatric regulatory strategy and submissions, including direct involvement in pediatric development, submission preparation, and health authority interactions.
• Must have recent significant experience with EU regulatory submission strategy, structure, and content, including MAAs, CTAs, pediatric submissions, briefing documents, and other European regulatory filings.
• Demonstrated track record of successful regulatory interactions with the EMA, EU National Competent Authorities, MHRA, Swissmedic, and other applicable health authorities supporting major submissions and product approvals.
• Proven success 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 to development programs from early development through registration and lifecycle management.
• Excellent written, verbal, presentation, and influencing skills, with the ability to communicate complex regulatory strategies and risks to senior management, health authorities, consultants, and external partners.
• Proven analytical, problem-solving, organizational, negotiation, and decision-making skills, with the ability to develop regulatory strategies and compelling, data-driven regulatory narratives.
• Demonstrated ability to thrive in a fast-paced, innovative environment while fostering collaboration, open communication, and alignment among diverse stakeholders.

Additional Preferences

• 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.
• Intrinsically curious and deeply passionate about the work we do.

Work Location
The Senior Director, Global Regulatory Strategy role is based in the UK with occasional travel including to the US.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.