EU Regulatory Affairs Leader, T1D Therapies

Breakthrough T1D; Belgique; Vor Ort; EUR 100.000 - 165.000; Vollzeit

Benefits dieser Stelle

Medical coverage

Dental coverage

Vision coverage

403(b) plan

Flexible spending

Commuter benefits

Employee assistance program

Life and disability insurance

Performance bonuses

Generous paid time off

Zusammenfassung

Breakthrough T1D seeks a senior Regulatory Affairs leader to implement its EU regulatory strategy for T1D therapies, including cell and disease-modifying approaches, with a focus on biomarker advances and digital health tools.

You will lead regulatory strategy, engage with the EMA and national authorities, and collaborate across Research, Advocacy and Medical Affairs to accelerate development. Travel about 10%.

Qualifikationen

• 8+ years in regulatory affairs or regulatory science in medical products.
• Deep knowledge of EU regulatory laws and guidelines.
• Experience leading regulatory strategy across EU and collaboration with EMA.
• Track record of regulatory policy success.
• Ability to travel 10%.
• Excellent written and oral communication.

Aufgaben

• Lead EU regulatory strategy for T1D therapies including cell therapies and disease-modifying approaches.
• Engage with the European Medicines Agency and national authorities.
• Collaborate with Advocacy, Research, and Medical Affairs.
• Identify regulatory science challenges and propose solutions.
• Report to leadership on regulatory issues in the EU.
• Oversee outside regulatory advisors or consultants.
• Coordinate with Breakthrough T1D Affiliates on strategy.
• Track EU legislative developments and implications.

Jobbeschreibung

Breakthrough T1D seeks a senior Regulatory Affairs leader to implement its EU regulatory strategy for T1D therapies, including cell and disease-modifying approaches, with a focus on biomarker advances and digital health tools.

You will lead regulatory strategy, engage with the EMA and national authorities, and collaborate across Research, Advocacy and Medical Affairs to accelerate development. Travel about 10%.