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Senior Director, European Regulatory Strategy Lead

Lilly· Research & Development
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Indianapolis, Indiana, United States of AmericaFull TimePosted 1w ago

About the role

Senior leadership role focused on European regulatory strategy within R&D, responsible for shaping regulatory approach and leading efforts across Europe.

Responsibilities

  • Leading development and execution of European regulatory strategy for products in scope
  • Collaborating with cross-functional teams (regulatory, clinical, quality, and development) to ensure compliant product development and submissions
  • Providing strategic regulatory guidance to senior leadership and project teams
  • Overseeing regulatory submissions and interactions with European authorities
  • Managing risk assessment and development of regulatory pathways and timelines

Qualifications

  • Senior-level regulatory affairs leadership experience in the European market
  • Proven ability to develop and implement regulatory strategies for multiple product indications
  • Strong collaboration and cross-functional leadership skills
  • Experience with regulatory submissions to European authorities (e.g., EMA, national competent authorities) and health technology assessment interactions

Benefits

  • Benefits information not specified in the description.
Last updated Oct 16, 2026. Interested? Apply on the company site.

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