EU Director, Regulatory Affairs – Drug & Device Strategy

TFS HealthScience; Barcelona; A distancia; EUR 140.000 - 200.000; Jornada completa

Descripción de la vacante

TFS HealthScience is seeking an EU Director, Regulatory Affairs to lead regulatory strategy across device and drug development, working within the CDS Unit. This senior role focuses on EU CTR/CTIS programs and global regulatory initiatives, coordinating with study start-up and business units to optimize submissions and timelines.

Based in Europe, you will influence regulatory approaches for clinical investigations, orphan designation, pediatric plans, and scientific advice meetings, while

Formación

• Bachelor’s Degree in life science and 9+ years of relevant experience.
• Experience with international regulatory strategy for multi-national trials (EU CTR/CTIS).
• Experience with European scientific advice, orphan designation and Pediatric Investigation Plans.
• Experience supporting proposals, budgets, bid defenses for international customers.
• Ability to work in a fast-paced environment and interact with senior management.

Responsabilidades

• Lead European and global regulatory strategy support for Drug and Device projects.
• Support regulatory startup strategy for new device, drug, and combination products.
• Develop regulatory documents and provide EMA and national advice support.
• Lead regulatory development activities including Pediatric Investigation Plans and Orphan designations.
• Collaborate with US regulatory teams to align global strategies.
• Ensure compliance with SOPs, local laws, and regulations.

Conocimientos

Regulatory strategy

Leadership

Global regulatory

Scientific knowledge

Communication

Educación

Bachelor's degree in life science

Herramientas

CTIS (EU Clinical Trials Information System)

Descripción del empleo

TFS HealthScience is seeking an EU Director, Regulatory Affairs to lead regulatory strategy across device and drug development, working within the CDS Unit. This senior role focuses on EU CTR/CTIS programs and global regulatory initiatives, coordinating with study start-up and business units to optimize submissions and timelines.

Based in Europe, you will influence regulatory approaches for clinical investigations, orphan designation, pediatric plans, and scientific advice meetings, while