Senior Director, EU Regulatory Strategy — Lead Global Programs

Regulatory Jobs; United States; Presencial; USD 161.000 - 260.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Company bonus

401(k) plan

Comprehensive benefits

Descripción de la vacante

Centessa Pharmaceuticals, a subsidiary of Eli Lilly, seeks a Senior Director, European Regulatory Strategy to lead EU regulatory programs from development through registration and lifecycle management.

You will drive EU regulatory strategy, manage interactions with EMA, MHRA and Swissmedic, oversee pediatric submissions, and guide cross‑functional teams in a fast‑paced, matrixed environment while coordinating with global regulatory colleagues.

Formación

• Extensive EU regulatory strategy and submissions experience.
• Experience leading regulatory interactions with EMA, MHRA, Swissmedic.
• Strong leadership in matrixed development teams.

Responsabilidades

• Lead European regulatory strategy for lead programs through registration.
• Plan and submit MAAs, CTAs, and pediatric submissions.
• Represent the company in EU health authority meetings.
• Provide guidance to cross-functional teams on regulatory plans.
• Engage external EU regulatory consultants and vendors.

Conocimientos

Regulatory leadership

EU regulatory strategy

Health authority interactions

Cross-functional leadership

Regulatory submissions

Regulatory strategy

Educación

PhD/PharmD/MS/JD preferred

Descripción del empleo

Centessa Pharmaceuticals, a subsidiary of Eli Lilly, seeks a Senior Director, European Regulatory Strategy to lead EU regulatory programs from development through registration and lifecycle management.

You will drive EU regulatory strategy, manage interactions with EMA, MHRA and Swissmedic, oversee pediatric submissions, and guide cross‑functional teams in a fast‑paced, matrixed environment while coordinating with global regulatory colleagues.