EU Regulatory Affairs Lead—T1D Therapies & Innovation

Breakthrough T1D; Belgique; A distancia; EUR 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision coverage

403(b) retirement plan

Flexible spending accounts

Employee assistance program (EAP)

Life and disability insurance

Performance-based bonuses

Generous paid time off

Descripción de la vacante

Breakthrough T1D is seeking an experienced regulatory leader to implement EU regulatory strategy, drive regulatory science initiatives, and collaborate with EU and US teams. The role focuses on accelerating development and regulatory approval of therapies for type 1 diabetes.

The ideal candidate will have 8+ years of regulatory affairs experience, strong EU regulatory knowledge, and a proven ability to work across diverse teams to influence policy and practice.

Formación

• Excellent written and verbal communication skills across cross-functional teams.
• Demonstrated ability to work collaboratively across functions, geographies and organizations.
• Proven track record of regulatory policy, regulatory affairs or regulatory science work.

Responsabilidades

• Implement EU regulatory strategy to accelerate development and approval of T1D therapies.
• Identify regulatory challenges and propose solutions, incl. biomarkers, surrogate endpoints, real-world data.
• Engage with EU regulatory authorities and stakeholders to shape regulatory priorities.

Conocimientos

Written communication

Oral communication

Interpersonal skills

Collaboration

Educación

Advanced degree preferred (science/legal/business)

Descripción del empleo

Breakthrough T1D is seeking an experienced regulatory leader to implement EU regulatory strategy, drive regulatory science initiatives, and collaborate with EU and US teams. The role focuses on accelerating development and regulatory approval of therapies for type 1 diabetes.

The ideal candidate will have 8+ years of regulatory affairs experience, strong EU regulatory knowledge, and a proven ability to work across diverse teams to influence policy and practice.