Title:
Director, Regulatory Affairs, Labelling
Company:
Ipsen Biopharm Ltd
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!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Job Description:
Director, Regulatory Affairs, Labelling
WHAT - Summary & Purpose of the Position
- Lead the development and implementation of global labelling strategy for assigned products, across early and late-stage development, life cycle management (LCM), and marketed portfolios, ensuring alignment with asset strategy and maximizing future labelling opportunities.
- Serve as Global Labelling Therapeutic Area (TA) Lead for the assigned therapeutic area, providing strategic oversight across the portfolio, ensuring consistency of labelling approaches and key scientific positions, identifying portfolio-level risks and opportunities, and representing Global Labelling in cross-functional TA governance.
- Partner with senior leaders across Regulatory Affairs, Medical Affairs, Safety, Clinical Development and Commercial functions to influence product strategy, evidence generation and early label development. Contribute to clinical development plans and Target Product Label strategies to ensure alignment between clinical evidence generation and future labelling opportunities, consistent with the “CCDS as a driver” philosophy.
- Play a leading role in the transformation of Ipsen's future USPI operating model, including the progressive transition of USPI responsibilities into Global Labelling and the development of capabilities required for the future end-to end USPI ownership.
- Provide strategic oversight of core labelling (e.g., Company Core Data Sheets) and major market labelling, with a strong focus on US Prescribing Information (USPI) alongside EU product information, ensuring compliance with global regulatory requirements, current scientific and clinical evidence, and alignment across markets. Accountable for the quality, consistency and governance of labelling content globally, including interactions and negotiations with regulatory authorities supporting labelling development and approvals.
- Drive transformation, innovation and capability building across Global Labelling, including digitalisation, structured content approaches and AI-enabled solutions, while ensuring high-quality and timely delivery of labelling outputs.
WHAT - Main Responsibilities & Technical Competencies
Global Labelling Strategic Leadership:
- Define and drive the development of global labelling content strategies aligned with the asset strategy, regulatory requirements, labelling guidelines and Ipsen processes. Proactively develop labelling proposals and recommendations, lead cross-functional alignment and secure timely decisions through governance bodies.
- Lead the development and maintenance of core and major markets labelling (CCDS, USPI and EU PI), facilitating review and endorsement through the Labelling Team and Executive Labelling Committee, ensuring compliance, consistency and high-quality labelling outcomes throughout the product lifecycle.
- Act as Therapeutic Area (TA) Lead, providing strategic leadership and oversight across all products within the assigned TA, ensuring consistency of labelling strategy, scientific positions, key messaging, and regulatory approaches across development and marketed assets.
- Provide strategic guidance, coaching and functional leadership to Global Labelling professionals responsible for products within the TA, ensuring alignment with TA priorities, regulatory trends, and business objectives.
- Contribute to the development of the Target Product Label by defining key labelling product claims in early development programs, identifying labelling-relevant clinical endpoints, providing strategic input into the design of Phase 2 and Phase 3 clinical trials and assessing the integration of patient data (e.g. PRO, QoL…) .
- Contribute to regulatory agency interactions and negotiations involving labelling content; address inconsistencies in global labelling implementation or compliance.
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.
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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, including contributions to clinical protocol development and endpoint discussions.
Education / Certifications (essential):
- Advanced degree in life sciences, pharmacy, medicine or related field.
- Significant experience in regulatory affairs within the pharmaceutical or biotechnology industry, with substantial exposure to global labelling strategy, including USPI labelling strategy (US required).
Language(s) (essential):
#LI-MM1 #LI-hybrid
We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.