Regulatory and Start Up Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8cx9i7

Overview
As an RSU Specialist, you will lead country-specific site activation and regulatory activities within IQVIA's FSP team in Italy. You will act as the primary liaison for investigative sites and project teams, ensuring compliant, timely site activation and regulatory documentation. You will leverage local regulatory expertise to support timelines, risk mitigation, and cross-functional collaboration. This role offers the chance to influence start-up processes across diverse therapeutic areas in a global, growth-oriented environment.

Retribuzione / Benefits
- Home-based flexibility within Italy
- Opportunity to work on innovative and impactful clinical studies
- Exposure to a wide range of therapeutic areas and sponsors
- Global career development and advancement opportunities
- Collaborative and inclusive culture focused on growth and continuous learning
- Commitment to integrity in hiring and candidate honesty

Responsabilità
- Serve as the main point of contact for investigative sites, SAMs, Project Managers, and internal stakeholders




- Coordinate and execute country-specific site activation and regulatory activities
- Prepare, review, and distribute regulatory documentation for completeness and compliance
- Track submission, approval, and execution of essential documents (regulatory submissions, ethics committee submissions, ICFs, IP release, CTAs)
- Support contract negotiations and timelines
- Maintain accurate records in internal systems and tracking tools
- Monitor milestones and proactively identify risks with mitigation plans
- Provide local regulatory expertise to project teams and Site Activation Managers
- Perform quality reviews of site documentation
- Review site performance metrics and contribute to continuous process improvement
- Collaborate with sponsors and cross-functional teams to ensure successful study start-up and site activation delivery

Requisiti fondamentali
- Bachelor's Degree in Life Sciences or related discipline
- Approximately

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8cx9i7