EU Regulatory Strategy Director

Eli Lilly and Company; United States; A distancia; USD 161.000 - 260.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) plan

Pension plan

Medical, dental, vision benefits

Descripción de la vacante

Centessa Pharmaceuticals, a subsidiary of Eli Lilly, seeks a Senior Director, Global Regulatory Strategy in the UK to lead EU regulatory strategy for complex programs. You will oversee MAAs/CTAs, pediatric submissions, and EMA/MHRA interactions, guiding cross-functional teams and external partners through development and lifecycle management.

This role requires extensive EU experience, strategic acumen, and a track record of successful regulatory leadership in a fast-paced biopharma environment.

Formación

• Bachelor or higher in a scientific field with extensive regulatory leadership experience in pharma/biotech.
• Significant EU regulatory submission experience (MAAs, CTAs) and interactions with EMA, MHRA, Swissmedic.
• Proven ability to develop and execute regulatory strategies across EU/UK/others and lead pediatric submissions.

Responsabilidades

• Serve as European Regulatory Lead for lead program and other development programs.
• Develop and execute regulatory strategies to obtain and expand product registrations in the EU, UK, and beyond.
• Lead planning, preparation and submission of MAAs, CTAs and pediatric regulatory submissions.
• Represent the company in regulatory interactions with health authorities and lead meetings.
• Provide strategic regulatory guidance to cross-functional teams and external consultants.

Conocimientos

Regulatory strategy

EU regulatory submissions

Leadership

Cross-functional collaboration

Regulatory interactions

Strategic planning

Stakeholder management

Educación

PhD/PharmD/JD/MS

Descripción del empleo

Centessa Pharmaceuticals, a subsidiary of Eli Lilly, seeks a Senior Director, Global Regulatory Strategy in the UK to lead EU regulatory strategy for complex programs. You will oversee MAAs/CTAs, pediatric submissions, and EMA/MHRA interactions, guiding cross-functional teams and external partners through development and lifecycle management.

This role requires extensive EU experience, strategic acumen, and a track record of successful regulatory leadership in a fast-paced biopharma environment.