Director, Regulatory Affairs – Europe

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Execute Breakthrough T1D’s regulatory strategy in the EU to expedite the development, assessment, and regulatory endorsement of therapies for type 1 diabetes.

• Offer regulatory leadership across Breakthrough T1D’s EU initiatives, emphasizing regulatory affairs and science, evidence generation, clinical trial design, and ecosystem collaborations.

• Create solutions to regulatory and regulatory science challenges, including biomarkers, surrogate endpoints, clinical outcome assessments, digital health technologies, and real-world data/evidence.

• Help define regulatory priorities, viewpoints, and policies within the EU T1D development ecosystem.

• Establish and preserve relationships with T1D experts and regulatory stakeholders, such as the European Medicines Agency and national competent authorities.

• Collaborate with industry partners to tackle regulatory challenges and promote T1D product development.

• Provide regulatory counsel to Breakthrough T1D-funded researchers and initiatives.

• Monitor and assess EU legislative and regulatory policy changes, identifying implications and opportunities.

• Update Breakthrough T1D leadership on EU regulatory matters and report on progress.

• Recognize the need for external regulatory advisors or consultants and supervise their activities.

• Work in partnership with Breakthrough T1D Affiliates and the Research, Advocacy, and Medical Affairs teams.

• Carry out other assigned responsibilities.

⛳️ Requirements

• Advanced degree in a scientific, legal, or business field is preferred.

• Over 8 years of relevant experience in regulatory affairs, regulatory science, or other medical product development sectors.

• Experience related to type 1 diabetes is preferred.

• Comprehensive understanding of EU regulatory laws, guidelines, processes, and officials.

• Familiarity with other regulatory agencies or national competent authorities is a plus.

• Demonstrated success in regulatory policy, regulatory affairs, or regulatory science for complex medical therapies.

• Highly collaborative, with a proven ability to work effectively across functions, disciplines, geographies, and organizations.

• Experience in successfully managing projects and initiatives as part of a coordinated strategy.

• Preferred experience in engaging with a diverse range of external stakeholders, such as academic researchers, industry, and regulators.

• Ability to work both independently and in close coordination with other team members.

• Proficient in multi-tasking, setting priorities, and exhibiting flexibility and responsiveness.

• Exceptional written, oral, communication, and interpersonal skills.

• Willing to travel within Europe and to the U.S. (approximately 10%).

🏝️ Benefits

• Medical coverage.

• Dental coverage.

• Vision coverage.

• 403(b) retirement plan.

• Voluntary benefits.

• Flexible spending accounts.

• Commuter benefit accounts.

• Employee assistance program (EAP).

• Life insurance.

• Disability insurance.

• Performance-based bonuses.

• Generous paid time off.