Ergomed is seeking Regulatory Affairs professionals experienced in managing global complex clinical studies. The role involves leadership and functional representation for projects, managing SSU/regulatory tasks, and ensuring compliance with standards. It requires preparing regulatory information for submissions to FDA, EMA, and national authorities, and providing expert advice to clients, plus training junior staff.
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The Manager, Study Start Up and Regulatory is responsible for developing the strategy based on regulatory requirements and for completing study start-up and regulatory deliverables based on an established regulatory SSU RA management plan. They actively assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets.