Senior Director, Global Regulatory — Cardiometabolic

Amgen SA; United States; Remoto; USD 180.000 - 240.000; Tempo pieno

Vantaggi offerti da questo lavoro

Total Rewards Plan

Stock-based incentives

Flexible work models

Comprehensive benefits

Descrizione del lavoro

Amgen is seeking a Director of Global Regulatory Affairs for Cardiometabolic Disorders to lead regulatory strategy for obesity programs. You will shape cross-functional decisions, manage global interactions with health authorities, and oversee major submissions to FDA/EMA while addressing metabolic disease complexities.

You will build and mentor a high-performing global regulatory team, align regulatory plans with clinical and safety data, and drive strategic initiatives across regions to

Competenze

• Doctorate or Master’s with required regulatory experience.
• Expertise in regulatory strategy for obesity/metabolic disorders.
• Strong leadership and communication skills.
• Experience with FDA/EMA interactions.
• Real-world evidence and long-term outcomes knowledge is a plus.

Mansioni

• Develop global regulatory strategy for obesity and metabolic programs.
• Lead global regulatory team and cross-functional collaborations.
• Oversee regulatory submissions and health authority interactions.
• Ensure alignment with FDA/EMA guidance and evolving regulations.
• Mentor and develop regulatory talent across geographies.
• Represent regulatory strategy in senior governance discussions.

Conoscenze

Regulatory leadership

Strategic thinking

Cross-functional collaboration

Communication skills

Real-world evidence

Formazione

Doctorate degree

Master’s degree

Bachelor’s degree

Descrizione del lavoro

Amgen is seeking a Director of Global Regulatory Affairs for Cardiometabolic Disorders to lead regulatory strategy for obesity programs. You will shape cross-functional decisions, manage global interactions with health authorities, and oversee major submissions to FDA/EMA while addressing metabolic disease complexities.

You will build and mentor a high-performing global regulatory team, align regulatory plans with clinical and safety data, and drive strategic initiatives across regions to