Vice President, Head of Global Regulatory Operations

Regulatory Jobs; Cambridge (MA); Vor Ort; USD 250.000 - 380.000; Vollzeit

Zusammenfassung

Ipsen Innovation (SAS) is seeking a Vice President, Head of Global Regulatory Operations to drive enterprise leadership across Regulatory Operations and enable Ipsen's global regulatory strategy. You will lead regulatory data, digital platforms, submissions and labelling governance to achieve excellence.

As a member of the Global Regulatory Affairs Leadership Team, you will partner with R&D, Quality, Medical, IT and Commercial to accelerate regulatory delivery and transform operations through AI

Qualifikationen

• Executive leadership experience within Research & Development in a global biopharmaceutical organization.
• Deep expertise across regulatory submissions, regulatory data, publishing, labelling, regulatory information management and digital technologies.
• Proven experience leading enterprise digital transformation, automation and AI-enabled initiatives.
• Strong executive stakeholder management with demonstrated ability to influence senior leaders across R&D, Quality, Medical, Commercial and Digital.

Aufgaben

• Define the Global Regulatory Operations strategy, operating model and long-term capability roadmap.
• Lead the transformation of Regulatory Operations through digital innovation, AI, automation and data-driven decision making.
• Build a high-performing global organization delivering inspection readiness and sustainable performance.
• Provide enterprise governance for regulatory systems, data, submission management and labelling.

Kenntnisse

Executive leadership

Regulatory operations

Regulatory submissions

Digital transformation

AI & automation in RA

Stakeholder management

Ausbildung

Bachelor’s degree

MBA or executive training

Advanced degree preferred

Jobbeschreibung

Title:

Vice President, Head of Global Regulatory Operations

Company:

Ipsen Innovation (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 https://www.ipsen.com/and follow our latest news on LinkedIn and Instagram.

Job Description:

The Vice President, Head of Global Regulatory Operations provides enterprise leadership for Regulatory Operations across Global Regulatory Affairs (GRA), defining the long-term vision, operating model and capabilities required to enable Ipsen's global regulatory strategy. The role is accountable for ensuring world-class regulatory operations through excellence in regulatory data, digital platforms, submissions, labelling governance and operational execution.

As a member of the Global Regulatory Affairs Leadership Team, the VP partners across R&D, Quality, Medical, IT and Commercial functions to drive enterprise transformation, accelerate regulatory delivery and strengthen Ipsen's competitive advantage through innovation, digitalization and operational excellence.

The role is accountable for:

• Defining and executing the Global Regulatory Operations strategy aligned with Ipsen's corporate and R&D objectives.
• Leading the transformation of Regulatory Operations through digital innovation, AI, automation and data-driven decision making.
• Building a high-performing global organization that delivers operational excellence, inspection readiness and sustainable business performance.
• Providing enterprise governance for regulatory systems, regulatory data, submission management and global labelling.
• Driving a culture of collaboration, accountability, innovation and continuous improvement.

Main Responsibilities & Technical Competencies

Enterprise Leadership & Strategy

• Define the strategic direction, operating model and long-term capability roadmap for Global Regulatory Operations, ensuring alignment with Global Regulatory Affairs, R&D strategy and future business priorities.
• Lead a global leadership team, building organizational capability, succession plans and an inclusive, high-performing culture.
• Represent Regulatory Operations within executive governance forums and influence enterprise decision-making.

Operational Excellence

• Own enterprise performance across Regulatory Operations including regulatory data governance, publishing, submissions, labelling, regulatory systems and operational delivery.
• Establish KPIs, governance and performance dashboards to continuously improve quality, compliance, productivity and customer experience.
• Ensure inspection readiness and sustainable compliance with evolving global regulatory requirements.

Digital Transformation

• Define and deliver the digital transformation strategy for Regulatory Operations, leveraging AI, automation, structured content management and emerging technologies to improve efficiency, scalability and regulatory effectiveness.
• Partner with Digital & IT to modernize platforms, strengthen data governance and develop future-ready regulatory capabilities.

Labelling (CCDS, USPI and SmPC)

• Lead global labelling governance ensuring consistency and compliance; implement digital tools for labelling lifecycle management; explore AI-driven solutions for signal detection and automated updates.

Regulatory Project Management

• Provide strategic oversight for major submissions and regulatory milestones
• develop project dashboards and predictive analytics for risk management
• champion agile methodologies for faster delivery under submission, excellence
• Own and improve Submission Excellence process & playbook, support IND Excellence project

Compliance

• Support inspection readiness for audits of Global Regulatory Affairs
• Organizes and ensures compliance to global standards & laws applicable to Global Regulatory Affairs, ensuring all systems are in compliance with GRA requirements.

Enterprise Governance

• Establish enterprise governance for regulatory operations, ensuring clear decision-making, accountability, risk management and cross-functional alignment.
• Sponsor business process harmonization and continuous improvement initiatives across the regulatory value chain.

External Leadership

• Build strategic partnerships with Health Authorities, industry associations, technology vendors and external partners to position Ipsen at the forefront of Regulatory Operations innovation.

Financial & Resource Management

• Own the Global Regulatory Operations budget, vendor strategy and investment roadmap.
• Optimize organizational resources and external partnerships to deliver sustainable operational performance.

Knowledge & Experience

Knowledge & Experience (essential):

• Executive leadership experience within Research & Development in a complex, global biopharmaceutical organization.
• Proven experience developing and executing global operational strategies that support business growth and regulatory excellence.
• Demonstrated leadership of large global, geographically dispersed organisations through significant transformation and organisational change.
• Deep expertise across regulatory submissions, regulatory data, publishing, labelling, regulatory information management and digital technologies.
• Strong executive stakeholder management with demonstrated ability to influence senior leaders across R&D, Quality, Medical, Commercial and Digital.
• Proven experience leading enterprise digital transformation, automation and AI-enabled initiatives.
• Experience managing significant operational budgets, strategic vendors and outsourced partnerships.
• Demonstrated ability to build inclusive, high-performing organisations and develop future leadership capability.

Knowledge & Experience (preferred):

• At least 10 years’ experience managing a worldwide Regulatory team
• At least 15 years’ experience in Pharmaceutical Industry (R&D or Pharmacovigilance), 5 years’ experience working in regulatory affairs, experience in managing complex regulatory submissions
• Experience in Regulatory Tools Administration (mainly regulatory tracking database and EDMS)
• High level knowledge in IT tools used for electronic dossier management and publishing: electronic document management systems, publishing suites, regulatory tracking systems
• Experience in the Data management methodology implementation and Data integrity principles
• Experience in the management of regulatory data and the Regulatory Data Governance to ensure availability, usability, integrity and security of high-quality data for RA community
• Key business analyst skills
• Fluent with the review regulatory processes
• Demonstrable experience of leading successful engagement with key regulatory authorities
• Proven track record in building and leading teams of skilled regulatory professionals to deliver business

Education / Certifications (essential):

• Bachelor’s degree
• Evidence of management/leadership education (MBA or executive training)

Education / Certifications (preferred):

• Advanced degree preferred
• Background in IT technologies or life sciences preferred

Language(s) (essential):

• Good oral and written communication skills
• Fluent English

Language(s) (preferred):

• Fluent French (preferred)

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