TFS HealthScience is a leading general 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 role
As 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 general regulatory strategy support for the Business Units and support Business Development with new RFPs and regulatory strategies for device and drug development and clinical investigations




- European 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 Projects
- Regulatory support with setting up and maintaining country regulatory and startup intelligence
- Developing regulatory documents and leading support for EMA and European national scientific advice / protocol assistance meetings
- Lead 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 Startup
- Regulatory Support of capabilities and bid defense meetings
- Collaborate with USA regulatory teams to develop global regulatory strategies and provide regulatory guidance to internal and external customers
- Collaborate and communicate with other clinical development departments at TFS
- Support development of new processes & procedures
- May ident

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