TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a EU Director, Regulatory Affairs home based in the UK, Spain, Sweden, Germany or Portugal.
About this roleAs part of our CDS Unit you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. EU Director Regulatory Affairs Drug and Device Expert position is part of the Clinical Development Services organization supporting both the Business Units and the Study Start-up groups.
Key Responsibilities:




Lead and Support European and global regulatory strategy support for the Business Units and support Business Development with new RFPs and regulatory strategies for device and drug development and clinical investigationsEuropean and global support of the strategy teams at the Business Units to develop a Regulatory and Startup strategy for new device, drug and combination products focused on RFPs and ProjectsRegulatory support with setting up and maintaining country regulatory and startup intelligenceDeveloping regulatory documents and leading support for EMA and European national scientific advice / protocol assistance meetingsLead and support regulatory development support activities including Pediatric Investigation Plans, Orphan designation and other designations/support (e.g., PRIME)Regulatory support for setting up new systems for StartupRegulatory Support of capabilities and bid defense meetingsCollaborate with USA regulatory teams to develop general regulatory strategies and provide regulatory guidance to internal and external customersCollaborate and communicate with other clinical development departments at TFSSupport development of new processes & proceduresMay identify and develop new strategic ini

📌 Eu Director, Regulatory Affairs (Barcelona)
🏢 TFS HealthScience
📍 Barcelona