Associate Director, Global Regulatory Affairs

Company:
Ipsen Biopharmaceuticals Inc.

Ipsen is a mid‑sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas:
Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human‑centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at  and follow our latest news on Linked In and Instagram .

The Associate Director, Global Regulatory Affairs is accountable for the development, continuous adaptation, and execution of regulatory strategies for assigned programs within the portfolio, either directly or through supervision of Regulatory Asset Team members. This role ensures the effective implementation of regulatory strategies across development and marketed products for assigned regions or worldwide.

The position provides regulatory expertise to R&D, Franchise, and Commercial Operations and serves as the primary interface between these functions and Global Regulatory Affairs on all regulatory matters related to development and product maintenance. The role is responsible for ensuring flawless execution of regulatory activities and for applying innovative and compliant approaches in collaboration with cross‑functional teams and the regulatory science community.

The Associate Director is also responsible for regulatory intelligence within relevant disease areas, identifying and communicating emerging trends that may impact the business. The role requires maintaining a broad external perspective and may involve participating in external influencing activities with health authorities or trade associations, particularly where Ipsen’s regulatory policy may benefit from such engagement. In addition, the role leads or contributes to operational excellence initiatives within Global Regulatory Affairs.

• 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 relevant functions and Asset Team/Sub-teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; proposes remediation where possible.
• With Asset Team/Sub-teams, define appropriate strategy in terms of sequencing of indications, dosage forms and geographies.
• Establish optimal label with appropriate balance between commercial expectations, regulatory requirements, and development outcomes.
• Identify opportunities and limiting factors for optimal label and propose alternative solutions.
• Incorporate commercialization challenges into regulatory strategy (not limited to trademarks, licensing agreements, product…