Requirements: English
Company: Haybury
Region: Paris , le-de-France
Team Leader International Regulatory Operations (Responsable Oprations Affaires Rglementaires) A mid-sized, innovation-driven global biopharmaceutical company is seeking a Team Leader for International Regulatory Operations ( Responsable Oprations Affaires Rglementaires ) to play a pivotal role in advancing its international regulatory operations and submission division. In this key leadership position, youll guide a recently restructured team of 56 FTEs, bringing your expertise to streamline complex submission processes and ensure excellence in regulatory operations across international markets (excluding the US). You'll work in close collaboration with Global Regulatory Affairs to shape and implement operational best practices that support development programs and lifecycle management globally. Team Leadership Operations Management: Lead and develop a team of 56 Regulatory Operations professionals; set priorities, manage objectives, oversee departmental budget, and supervise external partners involved in submissions, data management, and document formatting. Regulatory Data Governance: Ensure the accuracy, integrity, and compliance of regulatory data; Regulatory Information Systems: Act as system owner for regulatory tools including RA databases and EDMS; Lead regulatory monitoring activities across EU and international markets to support proactive regulatory strategy. Master's degree in Life Sciences, Pharmacy, or equivalent. Experience in database management and project management in a regulatory environment. Team management and project management. Proficiency in regulatory information tools and systems.