About this role 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.
The Director, Regulatory Affairs, EU is responsible for leading and
executing regional and global regulatory strategies to support drug
and device development. This role ensures compliance with European
and international regulations while enabling efficient clinical
development and successful project delivery. As part of our SRS/FSP
team, you will be dedicated to one sponsor, a global pharmaceutical
or biotechnology company that is an industry leader within its
therapeutic area. 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 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 of
capabilities and bid defense meetings Qualifications Advanced
degree in Life Sciences, Pharmacy, Medicine, or a related field
Significant experience in regulatory affairs within pharmaceutical,
biotechnology, or CRO environments Strong knowledge of European
regulatory requirements and experience with EMA and national
authorities Proven ability to lead regulatory strategy and work
effectively with cross-functional and global teams Excellent
communication, organizational, and problem-solving skills What We
Offer We provide opportunities for personal and professional growth
in a rewarding environment. You will join a team that values
collaboration, quality, and making a difference in the lives of
patients. Our core values of Trust, Quality, Passion, Flexibility,
and Sustainability guide our decisions and shape our culture. By
aligning on these values, we foster collaboration, innovation, and
a shared commitment to excellence. Together, we make a difference.
A Bit More About Us Our journey began over 30 years ago in Sweden,
in the city of Lund. As a full-service global CRO, we build
solution-driven teams working toward a healthier future. Bringing
together over 600 professionals, TFS delivers tailored clinical
research services in more than 50 countries, offering versátil
clinical development and strategic resourcing solutions across key
therapeutic areas including Dermatology, Neuroscience, Oncology,
and Ophthalmology.

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