Director, Regulatory Affairs

JDRF Overview

JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers in chapters across the United States and our five international affiliates are dedicated to advocacy, community engagement, and our vision of a world without T1D. For more information, please visit JDRF Website or follow us on Twitter @JDRF.

Job Description

As a JDRF team member, you can look forward to interesting and challenging work, building strong relationships with fellow staff and our network of volunteers, and having a meaningful impact on the lives of everyone affected by this devastating disease. JDRF supports a diverse and inclusive workforce and is an Equal Opportunity Employer.

Broad Function and Scope of the Position:

Lead and develop JDRF strategy to accelerate regulatory approval of drugs, biologics and medical devices for priority type 1 diabetes therapies. Collaborate with Senior Director, Regulatory Affairs on strategies to advance priority drugs, biologics and/or medical devices.

Specific Responsibilities:

• Develop and implement JDRF strategies to accelerate regulatory approval for priority drugs, biologics, and medical devices such as beta cell replacement therapies, disease modifying immune therapies, and therapies to improve glucose control and complications associated with type 1 diabetes.
• Manage planning and engagement with industry partners regarding regulatory processes.
• Provide strategic assessment and support for JDRF funded academic investigators to ensure success for regulatory submission to conduct research studies.
• Interface directly with regulators as needed.
• Identify needs for outside regulatory advisors and oversee work.
• Assess legislative and regulatory policy proposals and collaborate with internal and external stakeholders to communicate impacts to JDRF mission and develop strategies to mitigate risks and advance priorities.
• Collaborate closely with members of the JDRF scientific, advocacy and communications teams.
• Report on progress and advise JDRF leadership and allies on regulatory issues as needed.
• Perform other duties as assigned by immediate supervisor.

Years of Experience:

5-10 years of related experience

Knowledge:

• Extensive knowledge of FDA drug/biologics and/or medical device regulatory guidance, processes, policy, and officials.
• Knowledge of diabetes-related therapies helpful but not necessary.
• Proficiency in Microsoft Office.

Other Requirements:

• Experience with developing, implementing, and leading product specific regulatory interactions with US FDA and/or other regulatory bodies for early and/or late clinical stage development programs OR experience developing, implementing, and leading regulatory policy initiatives.
• Proven track record of success in achieving approvals for complicated medical therapies desired.
• Self-starter that requires little supervision and can work and make judgments independently.
• Can effectively multi-task, establish priorities, and work in a fast-paced environment.
• Excellent written, oral, and communication skills.
• Travel (approximately 10%).

Education:

Advanced scientific or legal degree preferred.

Target Salary: $130-170k

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. JDRF will comply with all federal, state, and local laws.

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

Learn more here