Senior EU Regulatory Strategy Director

Lilly; Boston (MA); On-site; USD 161,000 - 260,000; Full time

Benefits offered by this job

401(k) match and pension plan

Comprehensive medical, dental, vision

Flexible benefits (FSA/HSA)

Job summary

Lilly is seeking a Senior Director, Global Regulatory Strategy based in the United Kingdom with occasional travel to the US. You will lead European regulatory strategies across development programs, manage interactions with EMA, MHRA, and Swissmedic, and guide pediatric regulatory submissions.

This is a senior, matrixed role driving regulatory excellence across a diverse portfolio. You will collaborate with global regulatory teams, mentor sub-teams, and oversee external consultants to ensure

Qualifications

• Bachelor's degree in a scientific discipline with 12+ years of regulatory affairs experience including 5+ years in a leadership role with substantial European experience.
• Advanced degree (PhD, PharmD, MS, or JD) is strongly preferred and beneficial for small molecule development.
• Extensive experience leading European regulatory strategies and submissions with EMA, NCAs, MHRA, Swissmedic and other authorities.
• Experience with EU pediatric regulatory strategy and submissions and direct health authority interactions.

Responsibilities

• Lead European regulatory strategy and submissions for development programs, including MAAs and CTAs.
• Direct regulatory interactions with EMA, NCAs, MHRA, Swissmedic, and other authorities.
• Provide strategic guidance to cross-functional teams to integrate regulatory considerations into development plans.
• Lead ex-US pediatric regulatory activities and interactions with health authorities.
• Oversee external EU regulatory consultants and vendors to support submissions.
• Ensure regulatory compliance and alignment across regions and programs.

Skills

Regulatory leadership

EU regulatory strategy

Health authority interactions

Cross-functional leadership

Pediatric development

Regulatory submissions

Education

Bachelor's in scientific discipline

Advanced degree (PhD/PharmD/MS/JD)

Job description

Lilly is seeking a Senior Director, Global Regulatory Strategy based in the United Kingdom with occasional travel to the US. You will lead European regulatory strategies across development programs, manage interactions with EMA, MHRA, and Swissmedic, and guide pediatric regulatory submissions.

This is a senior, matrixed role driving regulatory excellence across a diverse portfolio. You will collaborate with global regulatory teams, mentor sub-teams, and oversee external consultants to ensure