Director, Regulatory Affairs – Europe

Breakthrough T1D

. Implement Breakthrough T1D’s regulatory strategy in the EU to accelerate the development, evaluation, and regulatory approval of therapies for type 1 diabetes .

Posted 9/21/2026full-timeRemote • BelgiumLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive knowledge of EU regulatory laws and processes, with a proven track record in regulatory affairs and science for medical therapies. Capable of building relationships with regulatory stakeholders and managing projects within the T1D development ecosystem.

Highest-signal resume keywords

EU Regulatory AffairsRegulatory ScienceType 1 Diabetes ExperienceProject ManagementStakeholder Engagement

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Strategy ImplementationClinical Trial DesignEvidence GenerationBiomarkersSurrogate EndpointsDigital-Health TechnologiesReal-World EvidenceRegulatory Policy DevelopmentRegulatory GuidanceLegislative Tracking

Soft Skills

CollaborationCommunicationInterpersonal SkillsMulti-TaskingFlexibility

Certifications & Qualifications

Advanced Scientific DegreeLegal DegreeBusiness Degree

Industry Keywords

European Medicines AgencyNational Competent AuthoritiesMedical Product DevelopmentRegulatory ChallengesT1D Development Ecosystem

About the role

Key responsibilities & impact

Implement Breakthrough T1D’s regulatory strategy in the EU to accelerate the development, evaluation, and regulatory approval of therapies for type 1 diabetes
Provide regulatory leadership across Breakthrough T1D’s EU activities, focusing on regulatory affairs and science, evidence generation, clinical trial design, and ecosystem partnerships
Develop solutions to regulatory and regulatory science challenges, including biomarkers, surrogate endpoints, clinical outcome assessments, digital-health technologies, and real-world data/evidence
Help shape regulatory priorities, perspectives, and policies across the EU T1D development ecosystem
Build and maintain relationships with T1D experts and regulatory stakeholders, including the European Medicines Agency and national competent authorities
Engage industry partners to address regulatory challenges and advance T1D product development
Provide regulatory guidance to Breakthrough T1D-funded researchers and initiatives
Track and evaluate EU legislative and regulatory policy developments and identify implications and opportunities
Report progress and advise Breakthrough T1D leadership on EU regulatory issues
Identify needs for outside regulatory advisors or consultants and oversee their work
Collaborate with Breakthrough T1D Affiliates and Research, Advocacy, and Medical Affairs teams
Perform other duties as assigned

Requirements

What you’ll need

Advanced scientific, legal, or business degree preferred
8+ years of related experience in regulatory affairs, regulatory science, or other medical product development disciplines
Type 1 diabetes related experience preferred
Extensive knowledge of EU regulatory laws, guidelines, processes, and officials
Knowledge of other regulatory agencies or national competent authorities a plus
Proven track record of success in regulatory policy, regulatory affairs, or regulatory science for complicated medical therapies
Highly collaborative with demonstrated ability to work effectively across functions, disciplines, geographies, and organizations
Experience successfully managing projects and initiatives as part of a coordinated strategy
Experience working with a wide variety of external stakeholders, including academic researchers, industry, and regulators preferred
Ability to work independently and in close coordination with other staff
Ability to effectively multi-task, establish priorities, and demonstrate flexibility and responsiveness
Excellent written, oral, communication, and interpersonal skills
Willingness to travel within Europe and to the U.S. (approximately 10%)

Benefits

Comp & perks

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