Manager, Regulatory Affairs

24 Apr, 2022

Jobs

Manager, Regulatory Affairs

JDRF International
Washington, D.C.

Company Description

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 six international affiliates are dedicated to advocacy, community engagement, and our vision of a world without T1D. For more information please visit jdrf.org or follow us on Twitter @JDRF.

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.

 

Job Description

BROAD FUNCTION AND SCOPE OF THE POSITION:

•    Assist in executing JDRF’s strategy to accelerate regulatory approval of new products for priority type 1 diabetes (T1D) therapies.

SPECIFIC RESPONSIBILITIES:

•    Implement and support JDRF strategy to accelerate regulatory approval for priority T1D therapies, such as advanced diabetes technologies, disease modifying therapies, and cell replacement therapies.
•    Coordinate engagement with external stakeholders, such as consortia and industry partners.
•    Coordinate with JDRF funded academic sites to ensure they have the assistance they need to obtain approval for research studies.
•    Monitor and assess global regulatory intelligence and policy/guidance to identify areas of importance to JDRF research priorities
•    Manage development of JDRF comments to regulatory authorities.
•    Maintain regulatory resource database with regulatory correspondence, regulatory intelligence, and department documents.
•    Identify, track and provide regulatory updates on priority T1D therapies.
•    Manage processes and timelines for regulatory projects and events including workshops and regulatory agency engagement.
•    Collaborate closely with members of the JDRF advocacy and scientific teams and utilize consultants effectively.
•    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 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:

•    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.
•    Team player that has the ability to interface with all levels of staff and volunteers. Must develop, maintain, and utilize 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%).

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

Resumes without cover letters will not be considered

To protect the health and safety of our employees, all employees are required to be fully vaccinated for COVID-19 and have a COVID-19 booster shot regardless of location or position. This includes those with remote status. 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 and is an Equal Opportunity Employer.
All information will be kept confidential according to EEO guidelines.

Job posted: 2022-04-24