Requirements: English
Company: Haybury
Region: Paris , le-de-France
Team Leader International Regulatory Operations(Responsable Oprations Affaires Rglementaires) Join a dynamicglobal biopharmaceutical company shaping the future of regulatoryexcellence. A mid-sized, innovation-driven global biopharmaceuticalcompany is seeking a Team Leader for International RegulatoryOperations (Responsable Oprations Affaires Rglementaires) to playa pivotal role in advancing its international regulatory operationsand submission division. In this key leadership position, youllguide a recently restructured team of 56 FTEs, bringing yourexpertise to streamline complex submission processes and ensureexcellence in regulatory operations across international markets(excluding the US). You''ll work in close collaboration with GlobalRegulatory Affairs to shape and implement operational bestpractices that support development programs and lifecyclemanagement globally. This is an exciting opportunity to influenceregulatory direction at scale, contribute to strategic initiatives,and make a real impact in a company committed to deliveringinnovation and improving patient lives worldwide. Responsibilitiesinclude: Team Leadership & Operations Management: Lead anddevelop a team of 56 Regulatory Operations professionals; setpriorities, manage objectives, oversee departmental budget, andsupervise external partners involved in submissions, datamanagement, and document formatting. Regulatory Data Governance:Ensure the accuracy, integrity, and compliance of regulatory data;maintain alignment with IDMP standards; support the drafting andsubmission of key documents (e.g., PSMF, PSUR/PBRER, PQR);administer the CTIS portal in collaboration with support teams.Regulatory Information Systems: Act as system owner for regulatorytools including RA databases and EDMS; ensure systems remainvalidated and optimized; provide support for the RA Dashboard anddefine performance indicators to monitor efficiency. RegulatoryIntelligence Coordination: Lead regulatory monitoring activitiesacross EU and international markets to support proactive regulatorystrategy. Innovation & AI Integration: Identify, design, andimplement AI-driven solutions to enhance regulatory workflows,document analysis, and strategic foresight in anticipatingregulatory changes. Requirements for the role: - Master''s degree inLife Sciences, Pharmacy, or equivalent. - Experience in databasemanagement and project management in a regulatory environment. -Team management and project management. - Proficiency in regulatoryinformation tools and systems. - Knowledge of IDMP, XEVMPDstandards, and health authority submission requirements. - Skillsin regulatory monitoring and artificial intelligence applied toregulatory processes. If you have the skills and experience forthis opportunity and the ambition to take on this position, pleasecontact Vicki Taggart for further details or email your CV today. -By email: vicki.taggart@hayburysearch.com - By phone: +44 (0)1273059 648 - Whats App or Mobile: +44 (0)7881 555 382