Director, Regulatory Affairs – Europe

Job not on LinkedIn

🔥 1 minute ago

🇧🇪 Belgium – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Breakthrough T1D

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1970

🤝 Non-profit

🏥 Healthcare

🔬 Science

Non-profit • Healthcare • Science

Breakthrough T1D is a nonprofit organization (formerly JDRF) focused on curing and improving life with type 1 diabetes. It funds and coordinates research and clinical trials, advances therapy development and access, leads advocacy on issues like insulin affordability, and provides community support, education, local chapters, events, and fundraising to accelerate breakthroughs and improve daily management for people with T1D.

📋 Description

• 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

• 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

• 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