Head of Regulatory Submission Project Management

About Ipsen: 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!

Job Description:

The head of Regulatory Submission Project Management provides strategic and operational leadership for a unified Regulatory Project Management (Reg PM) organization overseeing both early-phase (IND and CTR) and late-phase (NDA/MAA/BLA) regulatory submissions globally. This role is accountable for establishing and leading a single, high-performing Regulatory Project Management group that ensures consistent, high-quality, and on-time delivery of regulatory submissions across the full product lifecycle. He/she partners closely with Global Regulatory Affairs, Clinical Development, Biometry, Portfolio Project Management, Pharmaceutical Development and other cross-functional stakeholders to drive submission excellence, risk mitigation, and continuous process improvement.

Main Responsibilities & Technical Competencies:

• Strategic Leadership & Governance: Establish, own and lead a single Regulatory Project Management function covering early development (INDs, CTRs, amendments, maintenance) and late-stage submissions (NDA, MAA, BLA, major variations and extensions). Define and implement a global regulatory submission project management strategy, aligned with Global Regulatory Affairs and RegOps objectives. Develop governance models, escalation pathways, and decision-making frameworks to support complex, cross-regional submissions.
• Submission Oversight (Early & Late Phase): Provide oversight and/or direct leadership for high-priority, complex, or high-risk submissions, including INDs, NDAs, MAAs, BLAs, and major lifecycle filings. Ensure robust submission planning, scenario planning, and risk/opportunity management across all development stages.
• Operational Excellence & Delivery: Ensure consistent execution of submission activities, including original applications and major variations. Oversee coordination of document authoring, review cycles, publishing readiness, and final submission delivery in collaboration with Publishing Leads.
• People & Team Leadership: Build, lead and develop a Regulatory Project Management organization, including hiring, onboarding, performance management, succession and capability building. Coach and mentor Regulatory Project Managers across experience levels, fostering a culture of accountability, collaboration, and continuous improvement.
• Process, Tools & Continuous Improvement: Act as the global champion for regulatory project management methodologies, tools, and best practices. Standardize and optimize processes for submission planning, tracking, risk management, and reporting.
• Cross-Functional & External Collaboration: Foster strong matrix collaboration across Regulatory Affairs, Clinical Development, PharmDev, Safety, Quality, and external partners. Influence without authority to align stakeholders around submission priorities, trade-offs, and decisions.

Behavioural Competencies Required:

• Manage Complexity (Thinking Dexterity): Makes sense of complex, sometimes contradictory inputs across regions/functions; develops scenarios and focuses the organisation on what truly matters for submission success.
• Influences (Being Intentional): Builds commitment across a global matrix without formal authority; balances multiple stakeholder needs, creates win-win solutions, and secures timely decisions in governance forums.
• Communicates Effectively (Being Intentional): Delivers crisp, structured, executive-ready messages; uses clear storytelling and reporting to drive decisions, alignment, and urgency around milestones.
• Ensures Accountability (Making a Real Impact): Promotes single-point accountability and clear ownership; follows through on commitments; creates an environment where accountabilities, timelines, and next steps are explicit and actively managed.
• Excellence in Execution (Making a Real Impact): Plans and prioritizes to meet commitments under pressure; sets clear KPIs and standards, anticipates risks, and consistently delivers outcomes.

Knowledge & Experience:

• Significant experience in the pharmaceutical or biotechnology industry.
• Minimum 10–15 years of experience in Regulatory Affairs/Pharmaceutical Project Management, including extensive regulatory submission and project management experience.
• Strong portfolio/program PM capability (critical path, scenario planning, dependency management, risk-based decision support).