EU Director, Regulatory Affairs

Description

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.

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 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

Qualifications: 

• 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

What We Offer

We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. 

Together we make a difference.