Global Regulatory Affairs: Associate Director

Ipsen ADR; Cambridge (MA); On-site; USD 190,000 - 240,000; Full time

Job summary

Ipsen Biopharmaceuticals Inc. in Cambridge, MA, seeks an Associate Director, Global Regulatory Affairs to shape regulatory strategies for development and marketed products worldwide.

You will guide regulatory asset teams and collaborate with R&D, Franchise, and Commercial Operations to ensure timely, compliant submissions. The role requires 7+ years in Regulatory Affairs, strong project management, excellent communication, and a proven ability to lead cross-functional teams.

Qualifications

• Significant experience in the pharmaceutical industry, including 7+ in Regulatory Affairs.
• Experience managing complex worldwide products/projects within a relevant therapeutic area.
• Fluent in English.

Responsibilities

• Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics).
• Provide regulatory input into the Integrated Asset Strategic Plan.
• In collaboration with other departments, define the optimal plan to reach the target product profile, taking into consideration the most favorable timing for all key markets.
• Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements.
• In collaboration with Asset Team/Sub-teams, ensure plan adaptation when needed and assess impact on timelines and label.
• Define appropriate strategy in terms of sequencing of indications, dosage forms and geographies.
• Establish optimal label with balance between commercial expectations, regulatory requirements, and development outcomes.
• Lead or contribute to regulatory due diligence and operational excellence initiatives within GRA.

Skills

Regulatory Affairs

Project management

Stakeholder management

Communication skills

Education

Advanced degree in scientific discipline

Job description

Ipsen Biopharmaceuticals Inc. in Cambridge, MA, seeks an Associate Director, Global Regulatory Affairs to shape regulatory strategies for development and marketed products worldwide.

You will guide regulatory asset teams and collaborate with R&D, Franchise, and Commercial Operations to ensure timely, compliant submissions. The role requires 7+ years in Regulatory Affairs, strong project management, excellent communication, and a proven ability to lead cross-functional teams.