Team Leader International Regulatory Operations (Responsable Oprations Affaires Rglementaires)
Join a dynamic global biopharmaceutical company shaping the future of regulatory excellence. 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. This is an exciting opportunity to influence regulatory direction at scale, contribute to strategic initiatives, and make a real impact in a company committed to delivering innovation and improving patient lives worldwide.
Responsibilities include:
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; maintain alignment with IDMP standards; support the drafting and submission 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 regulatory tools including RA databases and EDMS; ensure systems remain validated and optimized; provide support for the RA Dashboard and define performance indicators to monitor efficiency.
Regulatory Intelligence Coordination: Lead regulatory monitoring activities across EU and international markets to support proactive regulatory strategy.
Innovation & AI Integration: Identify, design, and implement AI-driven solutions to enhance regulatory workflows, document analysis, and strategic foresight in anticipating regulatory changes.
Requirements for the role:
If you have the skills and experience for this opportunity and the ambition to take on this position, please contact Vicki Taggart for further details or email your CV today.