EU Regulatory Strategy Senior Director

Eli Lilly and Company; Indianapolis (IN); Presencial; USD 161 000 - 260 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) plan

Pension

Medical, Dental, Vision

Flexible benefits

Paid time off

Resumo da oferta

Eli Lilly and Company seeks a Senior Director, Global Regulatory Strategy, to lead European regulatory programs and shape strategy across development and registration. You will interact with EMA, MHRA, and Swissmedic, guiding teams through pediatric submissions and lifecycle management.

Based in the UK with occasional travel to the US, you will drive regulatory excellence and collaboration across programs, ensuring alignment with global regulatory objectives.

Qualificações

• Bachelor's degree in a scientific discipline with 12+ years of progressive regulatory affairs experience, including 5+ years in regulatory leadership with significant European experience.
• Advanced degree (PhD, PharmD, MS, or JD) preferred and beneficial for small molecule development.
• Extensive EU regulatory knowledge and direct experience with EMA, UK, and Swissmedic interactions.

Responsabilidades

• Serve as the European Regulatory Lead for development programs across EU, UK, and Switzerland and other regions.
• Develop and execute regulatory strategies to obtain, maintain, and expand registrations in Europe.
• Lead major regulatory filings (MAAs, CTAs, pediatric submissions) and health authority interactions.
• Provide regulatory guidance to cross-functional teams and align development plans with regulatory requirements.
• Oversee external EU consultants and vendors to support submissions and lifecycle management.

Conhecimentos

Regulatory leadership

EU regulatory strategy

Cross-functional teams

Regulatory submissions

Strategic influence

Formação académica

Bachelor's degree in science

Advanced degree preferred

Descrição da oferta de emprego

Eli Lilly and Company seeks a Senior Director, Global Regulatory Strategy, to lead European regulatory programs and shape strategy across development and registration. You will interact with EMA, MHRA, and Swissmedic, guiding teams through pediatric submissions and lifecycle management.

Based in the UK with occasional travel to the US, you will drive regulatory excellence and collaboration across programs, ensuring alignment with global regulatory objectives.