EU Director, Regulatory Affairs

TFS HealthScience

1d•Remote

About The Position

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 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.

Requirements

Bachelor’s Degree, preferably in life science
9+ years of relevant experience
Experience with international regulatory strategy, guidance and support for multi-national clinical trials, particularly with EU CTR and CTIS
Experience with supporting European scientific advice, orphan designation and pediatric investigation plans
Accustomed to supporting request for proposal & budget reviews, capabilities and bid defence meetings for international customers
Able to work in a fast-paced environment with changing priorities
Understand the basic terminology and science associated with the assigned drugs
Previous experience with supporting and attending European scientific advice meetings and similar agency interactions

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 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 identify and develop new strategic initiatives including process improvements
Interact with senior management across disciplines
Ensure that the unit follow TFS SOPs & guidelines, local laws and regulations are followed