Director, Regulatory Affairs, Labelling

Overview

As Director, Regulatory Affairs, Labelling you will lead global labelling strategy for Ipsen’s products across development and lifecycle management. You will shape early labeling input with development teams and ensure USPI, EU labels, and core CDSs meet regulatory requirements and reflect current evidence. You’ll drive cross-functional alignment, governance decisions, and interface with authorities to secure label approvals. You’ll lead transformation efforts to standardize processes and build labelling capabilities, while mentoring the team. This is a high-impact role in a collaborative, regulatory-driven environment that steers labeling strategy across markets.

Responsibilities

• Develop and implement global labelling strategies aligned with asset plans and lifecycle objectives
• Provide strategic input into early development programs, trial design, and product claims; define Target Product Profile
• Create and maintain core labelling documents (CCDS) and major market labels (USPI, EU SmPC/PIL); manage CCDS reviews via Labelling Team and Executive Labelling Committee
• Lead cross-functional alignment on labelling positions and escalate issues to governance bodies
• Support regulatory interactions and negotiations on labeling content; respond to health authority questions or label revisions
• Oversee lifecycle management of CCDS, USPI, and EU PI; mentor team to enhance expertise and ensure US regulatory alignment
• Drive transformation initiatives such as process standardization, digitalisation, and structured content in labelling
• Monitor regulatory trends and competitor labeling to inform strategy and contingency planning
• Provide oversight of Global, Regional, and Local regulatory personnel and external partners; ensure labeling compliance across regions
• Ensure continuous improvement of labelling processes, templates, tools, and governance
• Manage labelling budgeting and stakeholder communication with compliance considerations

Key requirements

• Strong knowledge of global regulatory labelling requirements (FDA, EMA, ICH) and lifecycle best practices
• Expertise in CCDS development and major market labels (USPI, EU SmPC/PIL)
• Ability to define and implement global labelling strategies aligned with clinical programs
• Strong scientific and analytical capability to translate data into compliant labeling content
• Proven ability to operate in matrix environments and influence stakeholders
• Experience in regulatory interactions and labeling negotiations with health authorities
• Strong project management skills and delivery of high-quality labelling deliverables
• Continuous improvement mindset for processes, tools, and ways of working

• strategic leadership
• cross-functional collaboration
• stakeholder influencing
• Global labelling strategy development
• USPI development and alignment with US requirements
• CCDS creation and maintenance

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