Director, Regulatory Affairs - Europe

As the leading global type 1 diabetes (T1D) research and advocacy organization, Breakthrough T1D helps make everyday life with T1D better while driving toward cures. We invest in the most promising research to turn ideas into life-changing therapies and devices. We work with government, regulatory officials, and insurance companies to address issues that impact the T1D community -- breaking through barriers that limit access to care worldwide. We provide resources and guidance that makes it easier to live and thrive with T1D. This is more than a moment -- we're empowering a movement for the T1D community. Share your support and help educate and empower individuals facing type 1 diabetes.

Our mission is to improve lives today and tomorrow by accelerating life changing breakthroughs to treat, prevent and ultimately, cure T1D and its complications. Always, we are guided by a single purpose: As we drive towards curing type 1 diabetes, we help make everyday life better for the people who face it.

BROAD FUNCTION AND SCOPE OF THE POSITION:

• Working closely with the Senior Director, Regulatory Affairs and cross-functional colleagues in the European Union (EU) and the United States (US), implement Breakthrough T1D’s regulatory strategy in the EU, with the goal of accelerating the development, evaluation, and regulatory approval of therapies for type 1 diabetes (T1D).
• Provide regulatory leadership across Breakthrough T1D’s EU activities, with particular focus on regulatory affairs and regulatory science, evidence generation and clinical trial design, and engagement with partners across the T1D ecosystem.
• Strengthen Breakthrough T1D’s role as a leader in regulatory innovation across the EU.

SPECIFIC RESPONSIBILITIES:

• Implement Breakthrough T1D’s regulatory strategy to accelerate the development and regulatory approval of T1D products in the EU, including cell therapies, disease modifying therapies, and therapies to improve glucose control and address T1D-realted complications.
• Identify and develop solutions to key regulatory and regulatory science challenges in the development and approval of T1D therapies, including advancing T1D biomarkers and surrogate endpoints, clinical outcome assessments, use of digital-health technologies, use of real-world data/real-world evidence, and other approaches to accelerate the development of novel therapies.
• In close collaboration with Advocacy colleagues, help shape the regulatory priorities, perspectives, and policies of decision makers across the EU T1D development ecosystem
• Strengthen and expand Breakthrough T1D’s role as a leader and trusted partner in regulatory innovation in the EU
• Develop and maintain effective relationships with leading T1D experts and regulatory stakeholders in the EU, including leadership and staff at the European Medicines Agency and other national competent authorities.
• Engage with industry partners to understand and address regulatory challenges and advance regulatory approaches that support T1D product development in the EU.
• Provide regulatory guidance for Breakthrough T1D funded researchers and initiatives to help align research and evidence generation with regulatory expectations.
• Track, assess and evaluate relevant EU legislative and regulatory policy development and identify implications and opportunities for to advance Breakthrough T1D priorities.
• Report on progress and advise Breakthrough T1D leadership on regulatory issues in the EU, as needed.
• Identify needs for outside regulatory advisors or consultants and oversee work as necessary.
• Engage and collaborate with Breakthrough T1D Affiliates on overall strategy, common regulatory policy priorities, and approach to key decision makers.
• Collaborate closely with members of the Breakthrough T1D Research, Advocacy, and Medical Affairs programs
• Perform other duties as assigned by his/her immediate supervisor.

EDUCATION:

• Advanced scientific, legal, or business degree preferred.

YEARS OF EXPERIENCE:

• 8+ years of related experience in regulatory affairs, regulatory science, or other medical product development disciplines.
• Type 1 diabetes related experience preferred.

KNOWLEDGE:

• Extensive knowledge of EU regulatory laws, guidelines, processes, and officials. Knowledge of other regulatory agencies or national competent authorities a plus.

OTHER REQUIREMENTS:

• 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
• A self starter with 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.
• Travel within Europe and to the U.S. (approximately 10%).

Targeted salary range will be provided to candidate prior to initial phone screen.

Essential Functions:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools or controls. The employee is occasionally required to stand, walk, sit, reach with hands and arms, climb or balance, and stoop, kneel, crouch or crawl.

The employee must occasionally lift and/or move up to 25 pounds, and infrequently up to 50 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus.

The noise level in the work environment is usually moderate.

Benefits:

Breakthrough T1D offers competitive benefits, including medical, dental, and vision coverage, a 403(b) retirement plan, voluntary benefits, flexible spending and commuter benefit accounts, an employee assistance program (EAP), life and disability insurance, performance-based bonuses, and generous paid time off. Benefits may vary by job level and full time or part time status.

Additional information:

Requests for medical, religious, and other exemptions will be considered on an individual basis. Breakthrough T1D will comply with all federal, state, and local laws.

Breakthrough T1D supports a diverse and inclusive workforce.
Breakthrough T1D is an Equal Opportunity Employer.
All your information will be kept confidential according to EEO guidelines.