U.S. Regulatory Strategy – Obesity and Related Conditions, Senior Manager

Responsibilities

• Contribute to U.S. regulatory strategy with insights on obesity and metabolic conditions
• Apply scientific knowledge to inform regulatory strategies focused on clinical endpoints and safety considerations
• Align with GRL and market teams on development timelines and regulatory documentation
• Execute U.S. regulatory submissions and represent U.S. interests on global teams
• Lead and develop key regulatory documents like labels and briefing packages
• Drive U.S. labeling strategy execution and negotiate timelines with various teams
• Ensure compliance and monitor evolving U.S. regulatory environment

Qualifications

• Doctorate degree with 2 years of experience
• Master's degree with 6 years of experience
• Bachelor's degree with 8 years of experience
• Associate's degree with 10 years of experience
• High school diploma/GED with 12 years of experience in regulatory or related fields
• Minimum 2 years of direct people management or leadership experience
• Strong understanding of obesity and metabolic diseases is preferred
• Experience leading labeling strategy and health authority interactions is a plus
• Ability to work in a regulated environment with familiar policies and procedures

Pay

$149,396 – $202,125 annually

Schedule

Remote - US based candidates only, no visa sponsorship available