Regulatory and Start Up Manager - Portugal

Regulatory and Start Up Manager responsible for directing site activation, maintenance, and regulatory activities for selected studies/programs, including pre-award/bid defense, scope of work, and budget/resource oversight. Develop and implement the Management Plan per Scope of Work; ensure cross-functional collaboration across Regulatory & Site Activation with regions/countries to deliver regulatory approvals and study initiation in compliance with RSU plans. Produce and review technical/administrative documents to support business development and study initiation; provide regulatory and scientific support to enable efficient clinical trials while maintaining compliance. Oversee multi-regional/multi-protocol programs during start-up and maintenance, determine regulatory strategy for submissions, identify regulatory complexities, and propose practical solutions to support bids and execution. Assess regulatory landscape, disseminate regulatory intelligence, and support contract negotiations and essential document reviews. Collaborate with Quality Management to uphold quality standards; mentor colleagues; maintain internal systems (CTMS, trackers, timelines, project plans); may lead relationships with preferred IQVIA customers; contribute to monthly study budget planning and client trainings. Requires strong leadership, negotiations, and technical/regulatory writing skills, and up-to-date knowledge of GCP/ICH guidelines.