Job Title: Director, Regulatory Affairs, Labelling
Division: Global Regulatory Affairs, Regulatory Operations Summary & Purpose of the Position
Strategic leadership of global labelling:
Essential:
Division: Global Regulatory Affairs, Regulatory Operations Summary & Purpose of the Position
- Responsible for leading the development and implementation of global labelling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios.
- Play an active role in shaping labelling strategy early in product development by providing regulatory input into clinical development plans. This strategic input ensures alignment between clinical evidence generation and future labeling opportunities aligned with the “CCDS as a driver” philosophy.
- Ensure that 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, comply with global regulatory requirements, reflect current scientific and clinical evidence, and support the safe and effective use of Ipsen products.
- Accountable for the quality and consistency of labelling content across global markets, and actively contributes to interactions with regulatory authorities during labelling development and negotiation.
- Play a key role in driving transformation, process excellence, and capability building across Global Labelling by providing clear direction and ensuring high-quality and timely delivery of labelling outputs.
Strategic leadership of global labelling:
- Drive the development of global labelling strategies in alignment with the overall asset strategy and processes.
- Contribute to early development programs by identifying labeling-relevant clinical endpoints, provide strategic input into the design of Phase 2 and Phase 3 clinical trials, and contribute to the definition of the key product claims and the development of Target Product Profile.
- Develop and maintain core labelling documents and major market labels (e.g. CCDS, USPI, EU SmPC&PIL); manages and facilitates review of CCDSs and regional labelling via the Labelling Team and Executive Labelling Committee. Secures appropriate approvals on labelling decisions.
- Accountable for proposing and driving labelling positions, leading cross-functional alignment, and escalating key issues to governance committees to secure decisions.
- Support regulatory agency interactions and negotiations involving labeling content; contribute to strategy for responding to health authority questions or label revisions.
- Lead cross functionally the development and lifecycle management of CCDS, USPI and EU PI (SmPC/PIL) for assigned products.
- Mentor and guide the team to strengthen strategic and technical labelling expertise, including providing strategic oversight of USPI development and ensuring alignment with global labelling strategy and US regulatory requirements. Establish and continuously evolve best practices to deliver high-quality, consistent, and efficient global labelling across products and regions.
- Lead or contribute to strategic transformation initiatives, including labelling process standardisation, digitalisation, and structured content approaches, to enhance efficiency and consistency across global labelling activities.
- Monitor competitor intelligence, regulatory trends, and evolving guidance to inform labelling strategy; work with Regulatory Affairs strategist to research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities.
- Provide oversight to Global, Regional, and Local Regulatory personnel and external partners involved in the development or management of labelling content, and collaborate with regional and country teams to address labelling implementation and compliance issues.
- Provide strategic oversight of USPI development and ensure alignment between global labelling strategy and US regulatory requirements.
- Responsible for identifying and alerting management regarding any labelling issue.
- Provide input and may lead the improvement of global labeling processes, templates, tools and systems to improve efficiency, productivity, quality and consistency across products.
- Ensure right communication with stakeholders and in particular with compliance for the implementation of safety label changes
- Develop labelling internal guidance and maintains awareness, assesses and communicates impact on IPSEN business and products (liaising with Regulatory Intelligence colleagues as appropriate).
- Responsible for promoting labelling activities and processes across Ipsen organization to reinforce good understanding and compliance with labelling processes.
- Share guidance and learnings within the global Labelling team to build a strong expertise.
- Contributes towards effective planning of the GRA labelling budget.
- Drive Vision and Strategy: Define and drive a clear global labelling strategy aligned with asset development and lifecycle objectives. Anticipate regulatory and clinical trend to shape labelling opportunities early in development and ensure long-term value.
- 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.
- 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.
- Collaborate: Build strong partnerships across Global, Regional, and Local Regulatory teams, as well as cross-functional stakeholders and partners. Ensure alignment and consistency of labelling strategy and implementation across markets.
- Drive Engagement: Engage, guide, and develop team members and stakeholders to deliver high-quality labelling outcomes. Foster accountability, collaboration, and continuous development to strengthen global labelling capabilities.
Essential:
- Strong knowledge of global regulatory labelling requirements (FDA, EMA, ICH) and lifecycle labelling best practices.
- Demonstrated expertise in the development and maintenance of core labelling (CCDS) and major market labels, including USPI and EU SmPC/PIL.
- 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.
- 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.
- Prior experience managing or mentoring team members.
- 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).
- Fluent English
Vacancy posted a month ago
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