Global Regulatory Affairs Lead — Associate Director

Ipsen; Cambridge (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Ipsen Biopharmaceuticals Inc. is seeking an Associate Director, Global Regulatory Affairs in the Cambridge, MA area. The role leads regulatory strategy and execution for development and marketed products, interfacing with R&D, Franchise, and Commercial teams to ensure compliant, timely delivery.

The position requires 7+ years in Regulatory Affairs, advanced scientific education, and strong cross-functional leadership. Ipsen emphasizes collaboration, performance, and impact across global markets.

Qualifications

• 7+ years in Regulatory Affairs across global drug development.
• Experience managing complex worldwide products/projects in key geographies.
• Excellent written and oral communication; ability to distill complex information.
• Proven project management and cross-functional leadership.

Responsibilities

• Provide regulatory input into target product profiles and strategic plans.
• Define the optimal plan to reach the target product profile across key markets.
• Lead regulatory strategy, submissions, and interactions with health authorities.
• Monitor regulatory intelligence and promote external influencing activities.
• Collaborate to ensure timely, compliant execution and budget control.

Skills

Regulatory affairs leadership

Drug development experience

Regulatory strategy

Project management

Communication skills

Stakeholder management

Regulatory liaison with authorities

Negotiation skills

Education

Advanced degree in science

Job description

Ipsen Biopharmaceuticals Inc. is seeking an Associate Director, Global Regulatory Affairs in the Cambridge, MA area. The role leads regulatory strategy and execution for development and marketed products, interfacing with R&D, Franchise, and Commercial teams to ensure compliant, timely delivery.

The position requires 7+ years in Regulatory Affairs, advanced scientific education, and strong cross-functional leadership. Ipsen emphasizes collaboration, performance, and impact across global markets.