Global Regulatory Affairs: Associate Director & Strategist

Ipsen Biopharmaceuticals Inc.; Cambridge (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Ipsen Biopharmaceuticals Inc. seeks an Associate Director, Global Regulatory Affairs to lead regulatory strategies for our portfolio, coordinating with R&D, Franchise, and Commercial teams.

The role requires directing global regulatory activities, ensuring timely and compliant submissions, and driving continuous improvement across programs. Ideal candidates will have 7+ years in Regulatory Affairs, advanced scientific degree, and proven ability to influence stakeholders and manage complex

Qualifications

• 7+ years in Regulatory Affairs with global product experience.
• Excellent written and verbal communication skills.
• Demonstrated project management and cross-functional leadership.

Responsibilities

• Lead development and execution of regulatory strategies for global programs.
• Collaborate with cross-functional teams and health authorities.
• Provide regulatory input to product profiles, strategies, and launch plans.
• Oversee regulatory intelligence and ensure compliant execution.

Skills

Regulatory affairs

Drug development

Project management

Stakeholder management

Strategic thinking

Communication

Change management

FDA relations

Education

Advanced degree in scientific discipline

Job description

Ipsen Biopharmaceuticals Inc. seeks an Associate Director, Global Regulatory Affairs to lead regulatory strategies for our portfolio, coordinating with R&D, Franchise, and Commercial teams.

The role requires directing global regulatory activities, ensuring timely and compliant submissions, and driving continuous improvement across programs. Ideal candidates will have 7+ years in Regulatory Affairs, advanced scientific degree, and proven ability to influence stakeholders and manage complex