Associate Director, Global Regulatory Affairs

Summary & Purpose of the Position

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.

Main Responsibilities & Technical Competencies

• Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics).
• Provide regulatory input into the Integrated Asset Strategic Plan.
• 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.
• 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.
• Incorporate commercialization challenges into regulatory strategy.
• Carry strategy beyond Marketing Authorization, to incorporate Pricing & Reimbursement considerations.
• Ensure the establishment of CCDS and required safety plans for the assigned product.
• Ensure regional regulatory specificities and needs are incorporated into the global plans.
• Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards).
• Advocate to and seek buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies.
• Ensure potential risks have been identified and mitigation options proactively proposed.
• Accountable for the flawless execution and implementation of the related Global Regulatory plans and activities.
• Ensure outsourced activities are delivered on time and on budget.
• Review and input to all key documentation relevant to Franchise plans as required.
• Conduct regulatory due diligence assessment on external opportunities.
• Lead operational excellence initiatives within GRA.
• Continuously monitor the scientific evolution of the assigned diseases within the therapeutic area for its regulatory impact.
• Collect, record and share competitive regulatory information for Ipsen competitor products.
• Monitor the external environment to identify trends and assess potential impact on business.
• Promote activities and processes to reinforce good external influencing behaviours in the GRA organization.
• Build effective relationships with global regulators for professional communications on Ipsen strategy.
• Ensure timely and accurate information of regulatory developments to all stakeholders.
• Contribute towards effective planning of the GRA budget.
• Ensure all activities are conducted in line with Ipsen’s ethics and compliance policies.

Knowledge & Experience (Essential)

• Significant experience in the pharmaceutical industry, including 7+ in Regulatory Affairs.
• Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies.
• Excellent written and oral communication skills and delivers all communication with clarity and impact.
• Ability to distil key information from complex and extensive sources and present the information in a constructive way.
• Demonstrated project management capability in developing and implementing long-term plans and delivering large-scale projects.
• Consistent ability to foster strong matrix working and strong track record of facilitating groups of individuals to work together on innovative regulatory solutions.
• Strong interpersonal and negotiation skills with a proven ability to build strong personal networks.
• Demonstrated capability to influence decision makers both internally and externally.
• Strategic thinking with demonstrated success in deriving creative solutions to regulatory challenges.
• Continuous focus on performance improvement and excellence in execution.
• Demonstrated ability to lead change and communicate difficult messages effectively.

Knowledge & Experience (Preferred)

• Track record of building excellent relationships with FDA.
• Knowledge of EU and Asia Pacific (mainly China and Japan) regulatory environment would be a plus.
• Knowledge of medical device / drug device combination regulations is strongly preferred.

Education / Certifications (Essential)

Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences) is required.

Language(s) (Essential)

Fluent in English.