Ipsen Group
Cookie NoticeGlobal Medical Director Migraine page is loaded Global Medical Director Migrainelocations: London (UK)time type: Full timeposted on: Posted Todayjob requisition id: R-21135 Title: Global Medical Director Migraine 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 and follow our latest news on and . Job Description: Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases. Patient-Focused : The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy. Employee Care : We care for our employees, who are the ambassadors making a real difference. Bold Leadershi p: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions. Growth Opportunities : We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization. About the Role The Global Medical Affairs Director, Neurosciences (Migraine) supports the Global Brand Plan, product development and lifecycle management, in driving late-stage projects and global trials, coordinating local ones and providing medical guidance and expertise across organization and externally. Main Responsibilities Medical Strategy & Evidence Generation Lead the design and execution of strategic projects to generate scientific insights and address commercial, clinical, or data-related needs. Support the development of clinical and real-world evidence through clinical trials, database analyses, and investigator-initiated studies. Cross-Functional Collaboration Partner with internal teams across Medical Affairs, Brand, and Market Access to provide scientific input and align on product strategy. Contribute to publication planning, speaker training programs, advisory boards, and the development of field medical resources. Scientific Communication & External Engagement Represent the company at scientific meetings and conferences, engaging with healthcare professionals, medical societies, and regulatory bodies. Maintain regular communication with the external medical community to stay informed on field developments and provide expert guidance. Key Opinion Leader (KOL) Engagement Establish and nurture relationships with key opinion leaders, academic institutions, and clinical investigators to support scientific exchange and strategic alignment with the Medical Plan. Conference Participation Attend major medical conferences, coordinate Medical Affairs activities, and deliver presentations to external audiences as needed. Lifecycle Management Support Provide expert medical input into product lifecycle management (LCM) initiatives, ensuring alignment with long-term strategic goals. Qualifications Medical degree (MD) or advanced degree in a relevant scientific field (PhD, PharmD). Extensive experience in medical affairs within the pharmaceutical or biotechnology industry. Proven track record in managing global medical affairs activities and leading cross-functional teams. Strong understanding of clinical development, regulatory requirements, and compliance. Experience in developing and implementing medical strategies and evidence generation plans. Experience in the field of neurosciences or related therapeutic areas. Strong network and relationships with key opinion leaders and scientific societies. Experience in conducting and managing global clinical trials. Knowledge of real-world evidence generation and health economics. English fluency If you feel that this could be the right next step for you, we would be delighted to engage with your application. Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application. 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. Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.
Cookie NoticeGlobal Medical Director Migraine page is loaded Global Medical Director Migrainelocations: London (UK)time type: Full timeposted on: Posted Todayjob requisition id: R-21135 Title: Global Medical Director Migraine 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 and follow our latest news on and . Job Description: Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases. Patient-Focused : The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy. Employee Care : We care for our employees, who are the ambassadors making a real difference. Bold Leadershi p: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions. Growth Opportunities : We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization. About the Role The Global Medical Affairs Director, Neurosciences (Migraine) supports the Global Brand Plan, product development and lifecycle management, in driving late-stage projects and global trials, coordinating local ones and providing medical guidance and expertise across organization and externally. Main Responsibilities Medical Strategy & Evidence Generation Lead the design and execution of strategic projects to generate scientific insights and address commercial, clinical, or data-related needs. Support the development of clinical and real-world evidence through clinical trials, database analyses, and investigator-initiated studies. Cross-Functional Collaboration Partner with internal teams across Medical Affairs, Brand, and Market Access to provide scientific input and align on product strategy. Contribute to publication planning, speaker training programs, advisory boards, and the development of field medical resources. Scientific Communication & External Engagement Represent the company at scientific meetings and conferences, engaging with healthcare professionals, medical societies, and regulatory bodies. Maintain regular communication with the external medical community to stay informed on field developments and provide expert guidance. Key Opinion Leader (KOL) Engagement Establish and nurture relationships with key opinion leaders, academic institutions, and clinical investigators to support scientific exchange and strategic alignment with the Medical Plan. Conference Participation Attend major medical conferences, coordinate Medical Affairs activities, and deliver presentations to external audiences as needed. Lifecycle Management Support Provide expert medical input into product lifecycle management (LCM) initiatives, ensuring alignment with long-term strategic goals. Qualifications Medical degree (MD) or advanced degree in a relevant scientific field (PhD, PharmD). Extensive experience in medical affairs within the pharmaceutical or biotechnology industry. Proven track record in managing global medical affairs activities and leading cross-functional teams. Strong understanding of clinical development, regulatory requirements, and compliance. Experience in developing and implementing medical strategies and evidence generation plans. Experience in the field of neurosciences or related therapeutic areas. Strong network and relationships with key opinion leaders and scientific societies. Experience in conducting and managing global clinical trials. Knowledge of real-world evidence generation and health economics. English fluency If you feel that this could be the right next step for you, we would be delighted to engage with your application. Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you, we would be delighted to engage with your application. 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. Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.
Ipsen Group
Global Procurement Director: Transformation M/WApplylocations: London (UK)time type: Full timeposted on: Posted 8 Days Agojob requisition id: R-21614 Title: Global Procurement Director: Transformation M/W 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 and follow our latest news on LinkedIn and Instagram . Job Description: This role can be based in Paris or London.As part of Ipsen's Global Procurement transformation journey, we are seeking a Global Procurement Director - Transformation to lead the evolution of Procurement into a strategic, enterprise-wide value driver. This role goes beyond traditional procurement excellence. You will shape and drive global, transversal transformation across processes, digital capabilities, governance, operating models, and performance, ensuring Procurement fully contributes to Ipsen's business objectives. Reporting to the Head of Procurement Centre of Excellence, you will operate at the heart of the Procurement leadership agenda, with strong exposure to senior stakeholders across Finance, Digital, and Business functions. You will also act as Global Business Process Owner (GBPO) for Source-to-Pay (procurement scope), ensuring end-to-end process performance, adoption, and continuous improvement across the organization.# Key Responsibilities Lead Procurement Transformation Shape and drive Ipsen's global procurement transformation roadmap in alignment with corporate strategy Lead transversal initiatives across eg digital, process, ESG, risk and data Position Procurement as a key contributor to enterprise transformation and performance Drive Strategic Programs & Governance Lead high-visibility, cross-functional programs and PMO governance Ensure alignment with Finance transformation and enterprise priorities Engage senior stakeholders to drive adoption and business impact Elevate Process Excellence & Digital Capabilities Define and implement best-in-class procurement processes and governance frameworks Leverage digital tools and analytics to enable data-driven decision-making Shape next-generation procurement capabilities and systems Drive Performance & Value Creation Establish performance frameworks using KPIs and dashboards Ensure delivery of measurable outcomes and continuous improvement Promote accountability and performance culture Own S2P End-to-End as GBPO Drive harmonized and efficient S2P processes beyond systems Ensure adoption, continuous improvement and change management Deliver simplification and scalability across operations Build Capabilities & Drive Change Upskill Procurement and reinforce continuous improvement mindset Foster collaboration across global teams Embed strong business partnering culture Your Profile 12+ years experience in Procurement with exposure to transformation or CoE Strong track record in leading large-scale transformation initiatives Strong hands-on experience in S2P processes and digital procurement Ability to engage and influence senior stakeholders Strong analytical and strategic thinking skills Ability to work in a complex, global and matrix environment Excellent communication and leadership capabilities Fluent in English Why This Role Matters Transform and simplify ways of working across Procurement Enhance Procurement impact on enterprise performance Strengthen governance, digitalisation, and process excellence Deliver sustainable, measurable valueWe 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.
Global Procurement Director: Transformation M/WApplylocations: London (UK)time type: Full timeposted on: Posted 8 Days Agojob requisition id: R-21614 Title: Global Procurement Director: Transformation M/W 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 and follow our latest news on LinkedIn and Instagram . Job Description: This role can be based in Paris or London.As part of Ipsen's Global Procurement transformation journey, we are seeking a Global Procurement Director - Transformation to lead the evolution of Procurement into a strategic, enterprise-wide value driver. This role goes beyond traditional procurement excellence. You will shape and drive global, transversal transformation across processes, digital capabilities, governance, operating models, and performance, ensuring Procurement fully contributes to Ipsen's business objectives. Reporting to the Head of Procurement Centre of Excellence, you will operate at the heart of the Procurement leadership agenda, with strong exposure to senior stakeholders across Finance, Digital, and Business functions. You will also act as Global Business Process Owner (GBPO) for Source-to-Pay (procurement scope), ensuring end-to-end process performance, adoption, and continuous improvement across the organization.# Key Responsibilities Lead Procurement Transformation Shape and drive Ipsen's global procurement transformation roadmap in alignment with corporate strategy Lead transversal initiatives across eg digital, process, ESG, risk and data Position Procurement as a key contributor to enterprise transformation and performance Drive Strategic Programs & Governance Lead high-visibility, cross-functional programs and PMO governance Ensure alignment with Finance transformation and enterprise priorities Engage senior stakeholders to drive adoption and business impact Elevate Process Excellence & Digital Capabilities Define and implement best-in-class procurement processes and governance frameworks Leverage digital tools and analytics to enable data-driven decision-making Shape next-generation procurement capabilities and systems Drive Performance & Value Creation Establish performance frameworks using KPIs and dashboards Ensure delivery of measurable outcomes and continuous improvement Promote accountability and performance culture Own S2P End-to-End as GBPO Drive harmonized and efficient S2P processes beyond systems Ensure adoption, continuous improvement and change management Deliver simplification and scalability across operations Build Capabilities & Drive Change Upskill Procurement and reinforce continuous improvement mindset Foster collaboration across global teams Embed strong business partnering culture Your Profile 12+ years experience in Procurement with exposure to transformation or CoE Strong track record in leading large-scale transformation initiatives Strong hands-on experience in S2P processes and digital procurement Ability to engage and influence senior stakeholders Strong analytical and strategic thinking skills Ability to work in a complex, global and matrix environment Excellent communication and leadership capabilities Fluent in English Why This Role Matters Transform and simplify ways of working across Procurement Enhance Procurement impact on enterprise performance Strengthen governance, digitalisation, and process excellence Deliver sustainable, measurable valueWe 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.
Ipsen Group
Director, Regulatory Affairs, LabellingApplylocations: London (UK): Paristime type: Full timeposted on: Posted Todayjob requisition id: R-21756 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 and follow our latest news on LinkedIn and Instagram . Job Description: Job Title:Director, Regulatory Affairs, LabellingDivision / Function:Global Regulatory Affairs, Regulatory Operations WHAT - 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 . WHAT - Main Responsibilities & Technical Competencies 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. End-to-end ownership of core labelling deliverables with strong USPI oversight : 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 standardization, 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. Continuous improvement and team's capabilities : 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. 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 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. 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 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 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. Prior experience managing or mentoring team members. 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): Fluent English are committed to creating a workplace where everyone feels heard, valued . click apply for full job details
Director, Regulatory Affairs, LabellingApplylocations: London (UK): Paristime type: Full timeposted on: Posted Todayjob requisition id: R-21756 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 and follow our latest news on LinkedIn and Instagram . Job Description: Job Title:Director, Regulatory Affairs, LabellingDivision / Function:Global Regulatory Affairs, Regulatory Operations WHAT - 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 . WHAT - Main Responsibilities & Technical Competencies 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. End-to-end ownership of core labelling deliverables with strong USPI oversight : 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 standardization, 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. Continuous improvement and team's capabilities : 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. 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 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. 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 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 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. Prior experience managing or mentoring team members. 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): Fluent English are committed to creating a workplace where everyone feels heard, valued . click apply for full job details