Senior Global Regulatory Affairs Lead

Regulatory Toolkit; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Ipsen Biopharmaceuticals Inc. is seeking an Associate Director, Global Regulatory Affairs to lead regulatory strategies for development and marketed products worldwide.

The role provides regulatory expertise across R&D, Franchise, and Commercial Operations and interfaces with health authorities and cross-functional teams. You will influence regulatory decisions, manage complex programs, and lead operational excellence within Global Regulatory Affairs, ensuring timely and compliant execution

Qualifications

• Significant experience in the pharmaceutical industry with regulatory affairs focus.
• Ability to lead regulatory strategy across development and marketed products.
• Strong communication and cross-functional leadership skills.

Responsibilities

• Lead development and execution of regulatory strategies for assigned programs.
• Provide regulatory input to global asset teams and cross-functional partners.
• Serve as main interface with health authorities and external stakeholders.
• Drive regulatory intelligence and ensure compliant execution across regions.

Skills

Regulatory Affairs expertise

Regulatory strategy

Drug development knowledge

Cross-functional collaboration

Education

Advanced degree in scientific discipline

Job description

Ipsen Biopharmaceuticals Inc. is seeking an Associate Director, Global Regulatory Affairs to lead regulatory strategies for development and marketed products worldwide.

The role provides regulatory expertise across R&D, Franchise, and Commercial Operations and interfaces with health authorities and cross-functional teams. You will influence regulatory decisions, manage complex programs, and lead operational excellence within Global Regulatory Affairs, ensuring timely and compliant execution