Ipsen Group
Cookie Notice Title: Head of Regulatory Submission Project Management 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: Job Title: Head of Regulatory Submission Project management Division / Function: Global Regulatory Affairs - Regulatory Operations Manager's Job Title: VP/Head of RegOps Ipsen Job Profile: Regulatory Affairs - regulatory Excellence operations Location: Paris / Ballard or London / Paddington WHAT - Summary & Purpose of the Position The head of Regulatory Submission Project Management provides strategic and operational leadership for a unified Regulatory Project Management (Reg PM) organization overseeing both early-phase (IND and CTR) and late-phase (NDA/MAA/BLA) regulatory submissions globally.This role is accountable for establishing and leading a single, high-performing Regulatory Project Management group that ensures consistent, high-quality, and on-time delivery of regulatory submissions across the full product lifecycle. He/she partners closely with Global Regulatory Affairs, Clinical Development, Biometry, Portfolio Project Management, Pharmaceutical Development and other cross-functional stakeholders to drive submission excellence, risk mitigation, and continuous process improvement.The position directly oversees priority/high exposure submissions and acts as a senior advisor to GRA leadership on feasibility, resourcing and delivery assurance.He/she is responsible for people leadership, capability building, governance, and standardization of regulatory project management practices, acting as the enterprise excellence champion for submission planning and execution. WHAT - Main Responsibilities & Technical Competencies Strategic Leadership & Governance Establish, own and lead a single Regulatory Project Management function covering early development (INDs, CTRs, amendments, maintenance) and late-stage submissions (NDA, MAA, BLA, major variations and extensions). Define and implement a global regulatory submission project management strategy, aligned with Global Regulatory Affairs and RegOps objectives. Develop governance models, escalation pathways, and decision-making frameworks to support complex, cross-regional submissions. Single point accountable as a senior regulatory project management advisor to Global Regulatory Leadership for end-to-end submission delivery assurance across early/late submissions and major lifecycle fillings, ensuring "right first time" quality and on-time execution.Submission Oversight (Early & Late Phase) Provide oversight and/or direct leadership for high-priority, complex, or high-risk submissions, including INDs, NDAs, MAAs, BLAs, and major lifecycle filings. Ensure robust submission planning, scenario planning, and risk/opportunity management across all development stages. Provide direct leadership for priority/high-exposure submissions, ensuring integrated plans (critical path, dependencies, RACI), risk/issue logs, and decision tracking Ensure submission content plans are developed in partnership with GRLs and functional leads and are executed according to agreed quality and timing standards.Operational Excellence & Delivery Ensure consistent execution of submission activities, including: Original applications and major variations INDs, CTRs and amendments Oversee coordination of document authoring, review cycles, publishing readiness, and final submission delivery in collaboration with Publishing Leads. Own the governance for submission-related Health Authority interactions, ensuring robust preparation and rapid, high-quality responses to HA questions (planned Q&A process before questions arrive) Monitor submission metrics, timelines, and quality indicators; proactively identify and resolve risks that could impact submission success. Drive Submission Excellence / continuous improvement through standards, playbooks, metrics and lessons learned, improve cycle time and predictability across the portfolioPeople & Team Leadership Build, lead and develop a Regulatory Project Management organization, including hiring, onboarding, performance management, succession and capability building. Coach and mentor Regulatory Project Managers across experience levels, fostering a culture of accountability, collaboration, and continuous improvement. Allocate resources across early- and late-phase submissions to ensure optimal workload balance and prioritization. Act as a role model for project management excellence and collaborative matrix leadership.Process, Tools & Continuous Improvement Act as the global champion for regulatory project management methodologies, tools, and best practices. Standardize and optimize processes for submission planning, tracking, risk management, and reporting. Capture and share lessons learned across submissions to drive organizational learning.Cross-Functional & External Collaboration Foster strong matrix collaboration across Regulatory Affairs, Clinical Development, PharmDev, Safety, Quality, and external partners. Influence without authority to align stakeholders around submission priorities, trade-offs, and decisions. Represent the Regulatory Project Management function in senior governance forums and, as appropriate, in interactions with Health Authorities. HOW - Behavioural Competencies Required 1) Manage Complexity (Thinking Dexterity) Makes sense of complex, sometimes contradictory inputs across regions/functions; develops scenarios and focuses the organisation on what truly matters for submission success (critical path, trade-offs, priorities). 2) Influences (Being Intentional) Builds commitment across a global matrix without formal authority; balances multiple stakeholder needs, creates win-win solutions, and secures timely decisions in governance forums. 3) Communicates Effectively (Being Intentional) Delivers crisp, structured, executive-ready messages; "tells it how it is" respectfully; uses clear storytelling and reporting to drive decisions, alignment, and urgency around milestones. 4) Ensures Accountability (Making a Real Impact) Promotes single-point accountability and clear ownership; follows through on commitments; creates an environment where accountabilities, timelines, and next steps are explicit and actively managed. 5) Excellence in Execution (Making a Real Impact) Plans and prioritizes to meet commitments under pressure; sets clear KPIs and standards, anticipates risks, and consistently delivers outcomes-especially on priority, high-visibility submissions. HOW - Knowledge & Experience Knowledge & Experience (essential): Significant experience in the pharmaceutical or biotechnology industry. Minimum 10-15 years of experience in Regulatory Affairs/Pharmaceutical Project Management, including extensive regulatory submission and project management experience. Strong portfolio/program PM capability (critical path, scenario planning, dependency management, risk-based decision support).
Cookie Notice Title: Head of Regulatory Submission Project Management 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: Job Title: Head of Regulatory Submission Project management Division / Function: Global Regulatory Affairs - Regulatory Operations Manager's Job Title: VP/Head of RegOps Ipsen Job Profile: Regulatory Affairs - regulatory Excellence operations Location: Paris / Ballard or London / Paddington WHAT - Summary & Purpose of the Position The head of Regulatory Submission Project Management provides strategic and operational leadership for a unified Regulatory Project Management (Reg PM) organization overseeing both early-phase (IND and CTR) and late-phase (NDA/MAA/BLA) regulatory submissions globally.This role is accountable for establishing and leading a single, high-performing Regulatory Project Management group that ensures consistent, high-quality, and on-time delivery of regulatory submissions across the full product lifecycle. He/she partners closely with Global Regulatory Affairs, Clinical Development, Biometry, Portfolio Project Management, Pharmaceutical Development and other cross-functional stakeholders to drive submission excellence, risk mitigation, and continuous process improvement.The position directly oversees priority/high exposure submissions and acts as a senior advisor to GRA leadership on feasibility, resourcing and delivery assurance.He/she is responsible for people leadership, capability building, governance, and standardization of regulatory project management practices, acting as the enterprise excellence champion for submission planning and execution. WHAT - Main Responsibilities & Technical Competencies Strategic Leadership & Governance Establish, own and lead a single Regulatory Project Management function covering early development (INDs, CTRs, amendments, maintenance) and late-stage submissions (NDA, MAA, BLA, major variations and extensions). Define and implement a global regulatory submission project management strategy, aligned with Global Regulatory Affairs and RegOps objectives. Develop governance models, escalation pathways, and decision-making frameworks to support complex, cross-regional submissions. Single point accountable as a senior regulatory project management advisor to Global Regulatory Leadership for end-to-end submission delivery assurance across early/late submissions and major lifecycle fillings, ensuring "right first time" quality and on-time execution.Submission Oversight (Early & Late Phase) Provide oversight and/or direct leadership for high-priority, complex, or high-risk submissions, including INDs, NDAs, MAAs, BLAs, and major lifecycle filings. Ensure robust submission planning, scenario planning, and risk/opportunity management across all development stages. Provide direct leadership for priority/high-exposure submissions, ensuring integrated plans (critical path, dependencies, RACI), risk/issue logs, and decision tracking Ensure submission content plans are developed in partnership with GRLs and functional leads and are executed according to agreed quality and timing standards.Operational Excellence & Delivery Ensure consistent execution of submission activities, including: Original applications and major variations INDs, CTRs and amendments Oversee coordination of document authoring, review cycles, publishing readiness, and final submission delivery in collaboration with Publishing Leads. Own the governance for submission-related Health Authority interactions, ensuring robust preparation and rapid, high-quality responses to HA questions (planned Q&A process before questions arrive) Monitor submission metrics, timelines, and quality indicators; proactively identify and resolve risks that could impact submission success. Drive Submission Excellence / continuous improvement through standards, playbooks, metrics and lessons learned, improve cycle time and predictability across the portfolioPeople & Team Leadership Build, lead and develop a Regulatory Project Management organization, including hiring, onboarding, performance management, succession and capability building. Coach and mentor Regulatory Project Managers across experience levels, fostering a culture of accountability, collaboration, and continuous improvement. Allocate resources across early- and late-phase submissions to ensure optimal workload balance and prioritization. Act as a role model for project management excellence and collaborative matrix leadership.Process, Tools & Continuous Improvement Act as the global champion for regulatory project management methodologies, tools, and best practices. Standardize and optimize processes for submission planning, tracking, risk management, and reporting. Capture and share lessons learned across submissions to drive organizational learning.Cross-Functional & External Collaboration Foster strong matrix collaboration across Regulatory Affairs, Clinical Development, PharmDev, Safety, Quality, and external partners. Influence without authority to align stakeholders around submission priorities, trade-offs, and decisions. Represent the Regulatory Project Management function in senior governance forums and, as appropriate, in interactions with Health Authorities. HOW - Behavioural Competencies Required 1) Manage Complexity (Thinking Dexterity) Makes sense of complex, sometimes contradictory inputs across regions/functions; develops scenarios and focuses the organisation on what truly matters for submission success (critical path, trade-offs, priorities). 2) Influences (Being Intentional) Builds commitment across a global matrix without formal authority; balances multiple stakeholder needs, creates win-win solutions, and secures timely decisions in governance forums. 3) Communicates Effectively (Being Intentional) Delivers crisp, structured, executive-ready messages; "tells it how it is" respectfully; uses clear storytelling and reporting to drive decisions, alignment, and urgency around milestones. 4) Ensures Accountability (Making a Real Impact) Promotes single-point accountability and clear ownership; follows through on commitments; creates an environment where accountabilities, timelines, and next steps are explicit and actively managed. 5) Excellence in Execution (Making a Real Impact) Plans and prioritizes to meet commitments under pressure; sets clear KPIs and standards, anticipates risks, and consistently delivers outcomes-especially on priority, high-visibility submissions. HOW - Knowledge & Experience Knowledge & Experience (essential): Significant experience in the pharmaceutical or biotechnology industry. Minimum 10-15 years of experience in Regulatory Affairs/Pharmaceutical Project Management, including extensive regulatory submission and project management experience. Strong portfolio/program PM capability (critical path, scenario planning, dependency management, risk-based decision support).
Ipsen Group
Cookie Notice Chief Information Security Officer Title: Chief Information Security Officer Company: Ipsen Pharma (SAS) 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: The Chief Information Security Officer (CISO) is a strategic executive responsible for protecting the company's physical, digital, and intellectual assets. In a pharmaceutical context, this includes safeguarding sensitive R&D data, clinical trial information, patient privacy, and proprietary technologies. The CISO leads the development and execution of a comprehensive security strategy encompassing cybersecurity, regulatory compliance, physical security, and internal investigations. This role includes building and managing a multidisciplinary security and investigations team, ensuring alignment with business goals and regulatory requirements. WHAT - Main Responsibilities & Technical Competencies Strategic Leadership Develop and execute a forward-looking security strategy aligned with corporate objectives and industry trends. Advise executive leadership and the board on risk posture, threat landscape, and investment priorities. Lead cross-functional initiatives to embed security into digital transformation, innovation, and operational excellence. Establish KPIs and performance metrics to measure and improve security effectiveness. Cybersecurity & IT Security Oversee the design and implementation of cybersecurity architecture and controls. Ensure protection of IT infrastructure, cloud environments, and sensitive data. Lead incident response, threat intelligence, and vulnerability management programs. Maintain compliance with global standards (e.g., ISO 27001, NIST, GDPR, HIPAA). Governance, Risk & Compliance Develop and enforce enterprise-wide security policies and procedures. In alignment with the business ethics team, ensure compliance with pharmaceutical regulations (e.g., FDA, EMA, GxP). Conduct risk assessments, internal audits, and third-party security evaluations. Report regularly to senior leadership on risk mitigation and compliance status. Investigations & Incident Management Establish and lead an internal investigations function to address security breaches, misconduct, and regulatory violations. Build and manage a team of investigators and analysts with expertise in digital forensics, compliance, and legal coordination. Collaborate with HR, Legal, and external agencies on sensitive investigations and disciplinary actions. Ensure thorough documentation, reporting, and resolution of incidents in line with legal and regulatory standards. Fraud Management Develop and implement a fraud prevention and detection framework across the organization. Lead investigations into suspected fraud, misconduct, and financial irregularities. Collaborate with Finance, Legal, and Compliance to ensure timely resolution and reporting of fraud cases. Maintain a whistleblower program and ensure confidentiality and integrity in handling reports. Monitor fraud trends and proactively adjust controls and training programs. Team Management & Development Build and lead a multidisciplinary security team (cybersecurity, physical security, investigations, risk management). Define roles, responsibilities, and career development paths for team members. Foster a culture of accountability, agility, and continuous learning. Manage vendor relationships and external consultants as needed. Physical & Operational Security Oversee facility security, access control, and surveillance systems. Coordinate with facilities and operations on emergency preparedness and response. Develop and test business continuity and disaster recovery plans. Stakeholder Engagement Partner with various functions & business leaders including Legal, Regulatory Affairs, R&D, and Medical Affairs to align security with business needs. Lead security awareness and training programs across the organization. Represent the company in external forums, industry groups, and regulatory engagements. HOW - Knowledge & Experience Skills: Technical depth in cybersecurity and investigations Leadership and team development Fraud detection and prevention expertise Regulatory and compliance acumen Communication and stakeholder management Crisis and incident responseKnowledge & Experience: 15+ years of experience in security leadership, preferably in pharma or life sciences. Proven track record in strategic planning, investigations, fraud management, and team leadership. Certifications such as CISSP, CISM, CISA, CRISC, or CFE (Certified Fraud Examiner) are highly desirable. Strong understanding of regulatory environments and risk management frameworks.Education / Certifications : Bachelor's or Master's degree in Information Security, Computer Science, or related field.Language(s) : Fluency in English. Knowledge of European language is a plus for global roles.Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons " The Real Us ". La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. Soyons nous-même 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 Notice Chief Information Security Officer Title: Chief Information Security Officer Company: Ipsen Pharma (SAS) 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: The Chief Information Security Officer (CISO) is a strategic executive responsible for protecting the company's physical, digital, and intellectual assets. In a pharmaceutical context, this includes safeguarding sensitive R&D data, clinical trial information, patient privacy, and proprietary technologies. The CISO leads the development and execution of a comprehensive security strategy encompassing cybersecurity, regulatory compliance, physical security, and internal investigations. This role includes building and managing a multidisciplinary security and investigations team, ensuring alignment with business goals and regulatory requirements. WHAT - Main Responsibilities & Technical Competencies Strategic Leadership Develop and execute a forward-looking security strategy aligned with corporate objectives and industry trends. Advise executive leadership and the board on risk posture, threat landscape, and investment priorities. Lead cross-functional initiatives to embed security into digital transformation, innovation, and operational excellence. Establish KPIs and performance metrics to measure and improve security effectiveness. Cybersecurity & IT Security Oversee the design and implementation of cybersecurity architecture and controls. Ensure protection of IT infrastructure, cloud environments, and sensitive data. Lead incident response, threat intelligence, and vulnerability management programs. Maintain compliance with global standards (e.g., ISO 27001, NIST, GDPR, HIPAA). Governance, Risk & Compliance Develop and enforce enterprise-wide security policies and procedures. In alignment with the business ethics team, ensure compliance with pharmaceutical regulations (e.g., FDA, EMA, GxP). Conduct risk assessments, internal audits, and third-party security evaluations. Report regularly to senior leadership on risk mitigation and compliance status. Investigations & Incident Management Establish and lead an internal investigations function to address security breaches, misconduct, and regulatory violations. Build and manage a team of investigators and analysts with expertise in digital forensics, compliance, and legal coordination. Collaborate with HR, Legal, and external agencies on sensitive investigations and disciplinary actions. Ensure thorough documentation, reporting, and resolution of incidents in line with legal and regulatory standards. Fraud Management Develop and implement a fraud prevention and detection framework across the organization. Lead investigations into suspected fraud, misconduct, and financial irregularities. Collaborate with Finance, Legal, and Compliance to ensure timely resolution and reporting of fraud cases. Maintain a whistleblower program and ensure confidentiality and integrity in handling reports. Monitor fraud trends and proactively adjust controls and training programs. Team Management & Development Build and lead a multidisciplinary security team (cybersecurity, physical security, investigations, risk management). Define roles, responsibilities, and career development paths for team members. Foster a culture of accountability, agility, and continuous learning. Manage vendor relationships and external consultants as needed. Physical & Operational Security Oversee facility security, access control, and surveillance systems. Coordinate with facilities and operations on emergency preparedness and response. Develop and test business continuity and disaster recovery plans. Stakeholder Engagement Partner with various functions & business leaders including Legal, Regulatory Affairs, R&D, and Medical Affairs to align security with business needs. Lead security awareness and training programs across the organization. Represent the company in external forums, industry groups, and regulatory engagements. HOW - Knowledge & Experience Skills: Technical depth in cybersecurity and investigations Leadership and team development Fraud detection and prevention expertise Regulatory and compliance acumen Communication and stakeholder management Crisis and incident responseKnowledge & Experience: 15+ years of experience in security leadership, preferably in pharma or life sciences. Proven track record in strategic planning, investigations, fraud management, and team leadership. Certifications such as CISSP, CISM, CISA, CRISC, or CFE (Certified Fraud Examiner) are highly desirable. Strong understanding of regulatory environments and risk management frameworks.Education / Certifications : Bachelor's or Master's degree in Information Security, Computer Science, or related field.Language(s) : Fluency in English. Knowledge of European language is a plus for global roles.Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons " The Real Us ". La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. Soyons nous-même Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.