Head of Global Regulatory Operations
On-siteLondon, England, United Kingdom or Paris, Île-de-France, France
Job Summary
Define the long-term vision and operating model for Global Regulatory Operations, aligning strategy with corporate and R&D objectives. Lead a global team through digital transformation, leveraging AI and automation to modernize platforms and enhance submission excellence. Establish enterprise governance for regulatory data, labelling, and systems while ensuring inspection readiness and sustainable compliance. Drive collaboration across R&D, Quality, Medical, and Commercial functions to accelerate regulatory delivery and strengthen competitive advantage. Manage the operational budget and vendor strategy to optimize resources and deliver continuous improvement across the regulatory value chain.
Required Qualifications
- 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
- 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
- Bachelor's degree
- Evidence of management/leadership education (MBA or executive training)
- Good oral and written communication skills
- Fluent English
Desired Qualifications
- Advanced degree preferred
- Background in IT technologies or life sciences preferred
- Fluent French (preferred)
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