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Organization and Position Overview
Centessa Pharmaceuticals , a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders . Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.
As the Senior Director, European Regulatory Strategy , you will report to the SVP, Regulatory and Medical Writing and serve as a key member of our regulatory team, providing strategic and operational regulatory leadership across development programs with a primary focus on Europe. As the Regulatory Lead for assigned assets, you will develop and execute regulatory strategies spanning nonclinical, clinical, and registration activities, with a particular focus on the European Union, United Kingdom, and Switzerland. The role requires extensive experience leading European regulatory programs and managing interactions with health authorities, including the EMA, EU National Competent Authorities, MHRA, Swissmedic, and other applicable regulatory agencies.
In partnership with cross-functional development teams, you will provide regulatory guidance, lead regulatory sub-teams, and align stakeholders to support successful program advancement from development through registration and lifecycle management. The role requires demonstrated experience with pediatric development and regulatory submissions, including pediatric regulatory strategy and health authority interactions. Experience with regulatory programs in APAC, particularly Japan and China, is a plus. If you enjoy fast-pace environment, have had success operating within a matrixed organization and leveraging external regulatory consultants and vendors while driving regulatory excellence across the portfolio, you will thrive in this opportunity.
Responsibilities
Serve as the European Regulatory Lead for our lead program cleminorexton and other assigned development programs, providing strategic regulatory leadership from early development through registration and lifecycle management.
Develop and execute regulatory strategies to obtain, maintain, and expand product registrations across the European Union, United Kingdom, Switzerland, and other applicable regions.
Lead the planning, preparation, and submission of major regulatory filings, including Marketing Authorisation Applications (MAAs), Clinical Trial Applications (CTAs), pediatric regulatory submissions, briefing documents, and other regulatory submissions within scope of responsibility.
Represent the company in regulatory interactions and lead meetings with European health authorities, including the EMA, EU National Competent Authorities, MHRA, and Swissmedic.
Provide EU regulatory guidance and strategic input to cross-functional program teams, ensuring regulatory considerations are integrated into development plans and key business…