Manager, Regulatory Affairs

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 .

• Support the implementation of BreakthroughT1D’s strategy to accelerate regulatory approval for priority T1D therapies, such as advanced diabetes technologies, disease modifying therapies, and cell replacement therapies.
• Effectively manage BreakthroughT1D’s Regulatory Affairs team members and partners to ensure efficient completion of Breakthrough T1D’s Regulatory Affairs projects and tasks
• Manage processes and timelines for regulatory projects, including events, workshops, and regulatory agency engagement.
• Coordinate with BreakthroughT1D’s research program and research scientist to ensure appropriate regulatory support is provided for research grants and activities
• Coordinate engagement with external stakeholders, such as T1D consortia, researchers, consultants, and industry partners.
• Lead and support internal and external meetings, including managing meeting schedules, developing meeting agendas, and creating draft meeting materials, as needed.
• Serve as point of contact with staff at regulatory agencies for key activities, including meetings with regulators and scientific / research partnerships.
• Monitor, assess, and complete briefing memos on global regulatory intelligence and policy / guidance to identify areas of importance for BreakthroughT1D
• Manage development of BreakthroughT1D public comments to regulatory authorities.
• Maintain regulatory resources database with regulatory correspondence, regulatory intelligence, department documents, and other key resources.
• Identify, track and provide regulatory updates on priority T1D therapies as they progress through the development pipeline.
• Communicate regulatory updates to and collaborate closely with members of the BreakthroughT1D advocacy and scientific teams
• Support BreakthroughT1D’s marketing and communications team needs related to communications of key regulatory updates.
• Support administrative management and utilization of consultants.
• Assist in all of the Advocacy department’s daily operations, programs, projects, and tasks.
• Perform other duties as assigned by his / her immediate supervisor.

Qualifications

EDUCATION :

Bachelor's degree required. Focus in life sciences or related discipline preferred.

YEARS OF EXPERIENCE :

3-5 years of related experience required.

KNOWLEDGE :

• Knowledge of FDA regulatory guidance, processes, and officials preferred. Experience in European regulatory processes a plus.
• Experience developing PowerPoint presentations and other business communications.
• Proficiency in Microsoft Office.

OTHER REQUIREMENTS :

• Project management experience and demonstrated ability to support and drive all phases of a project life cycle, including planning, implementation, execution, and completion.
• Knowledge of the health challenges of diabetes and available diabetes therapies helpful but not necessary (will be provided).
• Demonstrated ability to learn technical and scientific information needed to advance project goals.
• Ability to multi-task effectively, to establish priorities, and to work in a fast-paced environment. Highly efficient in time management and can meet deadlines under pressure with high quality work.
• Detail-oriented and strong organizational skills. Capable of handling diversified assignments.
• Highly collaborative team player that has the ability to interface with all levels of staff and volunteers. Must develop, maintain, and utilize internal and external relationships.
• Ability to coordinate and gain consensus among a broad group of stakeholders.
• Excellent written, oral, and communication skills.
• Ability to work and make judgments independently and take initiative. Self-starter that requires little supervision.
• Some travel required (roughly 10%).

Target Salary Range : $65,000 - $90,000 based on experience

We prefer a hybrid schedule with 2-3 days a week in the Advocacy Office in DC; however, we will consider fully remote for the right candidate.

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.

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.