Global Labelling Capability Building and USPI Transformation:

• Coach, mentor and develop the Global labelling professionals, strengthening strategic and technical capabilities across the function.
• Play a leading role in the transformation of Ipsen’s future USPI operating model, supporting the transition of USPI responsibilities into Global Labelling and embedding new ways of working.
• Lead the development of the capabilities required for future end-to-end USPI ownership within Global Labelling and provide strategic oversight of USPI development to ensure alignment with global labelling strategy and US regulatory requirements.
• Lead or contribute to strategic transformation initiatives, including labelling process standardisation, digitalisation, and structured content approaches, to enhance efficiency, consistency and scalability across products and regions.
• Monitor competitor intelligence, regulatory trends, and evolving health authority expectations to inform labelling strategy, strengthen positioning and support regulatory negotiations.
• Collaborate with Regulatory Affairs Strategists to assess labels within the same therapeutic area, including competitor labelling, to inform labelling strategy, support the development of robust labelling positions and contingency approaches, and strengthen regulatory negotiation strategies.
• Provide strategic guidance and oversight to Global, Regional, and Local Regulatory teams and external partners involved in labelling activities, ensuring effective collaboration and consistent implementation of global labelling strategies.
• Ensure effective stakeholder engagement and communication across SMEs, Global Regulatory Leads, Compliance and other key functions, particularly for the implementation of safety-related labelling changes.
• Proactively identify, assess and escalate strategic labelling risks and opportunities to senior management and governance bodies.

Innovation, Continuous Improvement and Operational Excellence:

• Drive continuous improvement of global labelling processes, templates, tools and systems to enhance efficiency, productivity, quality and consistency across products and regions.
• Lead the development and implementation of best practices, standards and internal guidance to support high-quality and consistent global labelling activities.
• Assess emerging labelling-related regulations, guidelines and health authorities expectations, communicate their potential impact on IPSEN products and business in collaboration with Regulatory Intelligence colleagues.
• Champion innovation within Global Labelling through digitalisation, structured content approaches and AI-enabled solutions that enhance operational effectiveness and future readiness.
• Promote knowledge sharing, capability enhancement and adoption of labelling processes across the organisation to reinforce compliance and organisational effectiveness.
• Contribute to resource planning and the effective management of the Global Labelling budget to support departmental objectives.

HOW - Behavioural Competencies Required

Drive Vision and Strategy

• Define and drive a clear global labelling strategy aligned with asset development and lifecycle objectives.
• Anticipate regulatory and clinical trends to shape labelling opportunities early in development and ensure long-term value.
• Demonstrate a forward-looking vision for the future of labelling, including the application of digital and AI-enabled solutions.

Manage Complexity

• Integrate complex and sometimes conflicting inputs (clinical, regulatory, safety, and regional requirements) into robust labelling decisions.
• Operate effectively in ambiguous environments, prioritising key issues and managing risks proactively.
• Navigate the complexity of Product Information while maintaining scientific robustness, accessibility and regulatory compliance.

Influence

• Drive alignment and decision-making across cross-functional and matrix teams without direct authority.
• Effectively advocate labelling positions using strong scientific and regulatory rationale, including for major markets such as the US, in governance forums and external interactions.
• Build strong partnerships with Global Regulatory Leads, Medical, Safety and other SMEs to develop and secure alignment on strategic labelling recommendations.

Collaborate

• Build strong partnerships across Global, Regional, and Local Regulatory teams, as well as cross-functional stakeholders (in particular with SMEs) and partners.
• Ensure alignment and consistency of labelling strategy and implementation across markets.

Drive Engagement

Engage, guide, and develop knowledge of team members and stakeholders, breaking down organisational silos to deliver consistent and effective global labelling strategies.

• Foster accountability, collaboration, teamwork and continuous development to strengthen global labelling capabilities.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Strong knowledge of global regulatory labelling requirements (FDA, EMA, ICH) and lifecycle labelling best practices.
• Demonstrated expertise in the development and maintenance of CCDS, USPI and EU PI (SmPC/PIL).
• Strong ability to develop strategic proposals, influence stakeholders and drive labelling recommendations.
• Demonstrated experience providing strategic leadership across multiple products within a therapeutic area, including portfolio-level oversight, prioritisation, and stakeholder engagement.
• Proven ability to define and implement global labelling strategies, including contribution to early development and alignment with clinical programs.
• Strong scientific and analytical capability to interpret complex data and translate it into clear, compliant, and strategically sound labelling content.
• Proven ability to operate effectively in matrix environments, influencing cross-functional stakeholders and driving alignment on key labelling decisions.
• Experience in regulatory interactions and labelling negotiations with health authorities and/or support to such activities.
• Strong project management skills, with the ability to manage multiple priorities and ensure high-quality and timely delivery of labelling deliverables.
• Continuous improvement mindset, with the ability to identify opportunities to enhance labelling processes, tools, and ways of working.

Knowledge & Experience (preferred):

• Experience across both development and marketed products, in global or multi-regional environments.
• Demonstrated involvement in early development labelling strategy, including input into clinical protocol design and endpoint discussions.
• Experience in mentoring, coaching, or developing team members within a global regulatory context.
• Experience with investigational and marketed products across multiple regions (US, EU required).
• Proven involvement in early development labelling strategy,