Senior Director, European Regulatory Strategy Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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. As the Regulatory Lead for assigned assets, you will develop and execute regulatory strategies spanning nonclinical, clinical, and registration activities, with a particular focus on the European Union, United Kingdom, and Switzerland. The role requires extensive experience leading European regulatory programs and managing interactions with health authorities, including the EMA, EU National Competent Authorities, MHRA, Swissmedic, and other applicable regulatory agencies.

In partnership with cross-functional development teams, you will provide regulatory guidance, lead regulatory sub-teams, and align stakeholders to support successful program advancement from development through registration and lifecycle management. The role requires demonstrated experience with pediatric development and regulatory submissions, including pediatric regulatory strategy and health authority interactions. Experience with regulatory programs in APAC, particularly Japan and China, is a plus. If you enjoy fast-pace environment, have had success operating within a matrixed organization and leveraging external regulatory consultants and vendors while driving regulatory excellence across the portfolio, you will thrive in this opportunity.

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. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

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