Global Study Start-Up Lead: Regulatory Submissions

Novo Nordisk is seeking a Senior Study Start-up Specialist in Italy to drive regulatory submissions and site activations for clinical trials. You will manage end-to-end study start-up, ensuring timely approvals and compliance with local and international regulations. You will coordinate with internal and externalStakeholders, maintain trial master file, and...

Every clinical trial begins with a critical first step – getting sites ready to enroll patients. In this role, you'll be the driving force behind regulatory and ethics submissions that open the door for breakthrough therapies to reach the people who need them. Your new role As a Senior Study Start-up Specialist, you will play a pivotal role in enabling...

Every clinical trial begins with a critical first step – getting sites ready to enroll patients. In this role, you'll be the driving force behind regulatory and ethics submissions that open the door for breakthrough therapies to reach the people who need them. Your new role As a Senior Study Start-up Specialist, you will play a pivotal role in enabling...

Novo Nordisk A/S in Italy is seeking a Senior Study Start-up Specialist to drive regulatory submissions and site activation for clinical trials, ensuring compliance with ICH-GCP and local requirements. You will manage end-to-end start-up, coordinate with internal and external stakeholders, maintain trial master file, and support contracts and budgets in a...

Thermo Fisher Scientific in Rome, Italy seeks a Country Approval Specialist to manage and coordinate local regulatory submissions in line with global strategy. You will provide regulatory strategy guidance to internal clients and support start-up activities at the country level.Key responsibilities include coordinating MoH/EC submissions, maintaining...

Thermo Fisher Scientific in Italy is seeking a Regulatory Affairs Manager to lead global regulatory submissions and top-tier client engagements.Se le sue competenze, la sua esperienza e le sue qualifiche corrispondono a quelle descritte in questa panoramica, non ritardi l'invio della sua candidatura.You will coordinate strategies for Phase 1–4 trials,...

Overview In this role, you drive the study start-up process to enable timely, compliant trial initiation. You manage regulatory and ethics submissions and coordinate cross-functional colleagues to activate sites and enable patient access to investigational therapies. You will operate within a global trial portfolio, supporting continuous improvement and...

Thermo Fisher Scientific is seeking a Global Study Lead to drive end-to-end delivery of global oncology studies within a FSP model. Based in Italy, you will partner with cross-functional teams to ensure study timelines, quality and budget adherence, and regulatory compliance.You will lead complex MAP, PACT and PTA initiatives across the UK/EMEA, oversee...

Angelini Pharma is seeking a Senior Manager, Global Regulatory Strategy in Rome to drive regulatory strategy across key regions for the development pipeline. You will collaborate with R&D, Clinical Development, CMC, Safety and Quality to ensure timely submissions and approvals.You will monitor evolving regulatory requirements (FDA, EMA, ICH) and lead...