Global Regulatory Director — Cardiometabolic Disorders

BioSpace; Washington (District of Columbia); On-site; USD 190,000 - 300,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen seeks a Director of Global Regulatory Affairs Cardiometabolic Disorders to lead regulatory strategy for obesity and related metabolic programs. You will drive global submissions, advise on study designs, safety assessments, and labeling decisions, and engage with health authorities worldwide.

This role requires leadership across Clinical Development, Safety, CMC, and Commercial teams. You will shape regulatory pathways, develop strategic plans, and ensure regulatory excellence across

Qualifications

• Doctorate/Masters/Bachelors with regulatory experience

Responsibilities

• Develop and lead global regulatory strategy for obesity and metabolic programs.
• Lead interactions with FDA/EMA and other authorities.
• Oversee major global regulatory submissions and labeling updates.
• Mentor Global Regulatory Team and partner with cross-functional functions.

Skills

Regulatory leadership

Global regulatory strategy

Cross-functional collaboration

Regulatory submissions

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

Amgen seeks a Director of Global Regulatory Affairs Cardiometabolic Disorders to lead regulatory strategy for obesity and related metabolic programs. You will drive global submissions, advise on study designs, safety assessments, and labeling decisions, and engage with health authorities worldwide.

This role requires leadership across Clinical Development, Safety, CMC, and Commercial teams. You will shape regulatory pathways, develop strategic plans, and ensure regulatory excellence across