Senior Director of Policy & Regulatory Affairs

About NORD

The National Organization for Rare Disorders (NORD) is the leading independent nonprofit organization representing all patients and families affected by rare diseases. Come join our team and be part of the transformation and acceleration of research, and the development of evidence-based policy, care support and awareness campaigns to improve the lives of the 30 million Americans impacted by rare diseases. We offer a competitive compensation and benefits package along with a collaborative work atmosphere, opportunities for career growth and development and flexible telecommuting options. Follow NORD at www.rarediseases.org/ and on Twitter at @RareDiseases.

Position Summary

Working in collaboration with NORD’s Vice President of Policy and Regulatory Affairs, the Senior Director of Policy and Regulatory Affairs is responsible for crafting and implementing NORD’s rare disease policy and advocacy engagement strategy with federal regulatory bodies, specifically the Food and Drug Administration (FDA) and National Institutes of Health (NIH). In addition, the Senior Director of Policy and Regulatory Affairs will lead NORD’s legislative and regulatory policy development as it relates to medical research and development in an effort to promote access to safe, effective diagnostics and treatments for rare disease patients. Experience with and knowledge of the development and regulation of such products by the Food and Drug Administration (FDA) and National Institutes of Health (NIH) is essential. The Senior Director will be responsible for independently and proactively drafting legislative and regulatory comments and proposals to benefit or protect the interests of the rare disease patient community, as well as research and craft NORD’s position or comments in response to pending legislative or regulatory proposals related to FDA and NIH. The Senior Director will be tasked with identifying and seizing opportunities to represent NORD and advance NORD’s organizational priorities at meetings with Congressional members and staff, Administration officials, regulatory agencies, member organizations and other interest groups. Excellent public speaking and writing skills are essential.

Essential Duties and Responsibilities

Collaborate with NORD’s Vice President of Policy and Regulatory affairs to craft and implement NORD’s policy and advocacy strategy to support medical research and development for rare diseases;

Lead NORD’s engagement with FDA and NIH to advance NORD organization and policy priorities that support development and approval of safe and effective therapies, devices, and diagnostics;

Effectively collaborate with internal NORD department leads, including the Chief Medical Officer, Research, Education and Development teams to identify and elevate organizational priorities with external stakeholders;

Establish and deepen critical stakeholder relations, including with federal regulatory bodies, other advocacy organizations, health care providers, drug manufacturers, and the media;

Manage policy analysts/policy managers and their work on legislative and regulatory proposals, including supporting their drafting testimony, correspondence, legislative amendments, floor statements and responses to rulemaking/guidance as it relates to the FDA and/or NIH;

Represent NORD in meetings with Congressional members and staff, Administration officials, and regulatory agency personnel;

Work in collaboration with like-minded stakeholders to coordinate efforts on legislative and/or regulatory issues;

Organize, attend, or participate in meetings or conferences as a representative of NORD;

Provide education to NORD membership organizations on the legislative and regulatory process;

Serve as a resource to NORD’s non-policy employees; and

Perform other duties and functions as assigned.

Education/Experience

MPH or similar degree required. J.D. or Ph.D. strongly preferred.

Strong FDA-related drugs & biologics policy and regulatory experience required; familiarity with Orphan Drug Act and User Fee Acts strong preferred.

Experience with NIH’s rare disease research portfolio.

At least 10 years of experience in public policy required.

Management experience is required.

A proven interest in and commitment to the rare disease community.

Knowledge, Skills and Abilities

In-depth knowledge of legislative and regulatory processes.

Excellent organizational, verbal and written communication skills.

Capable of handling a full range of delegated responsibilities and work independently.

Exercise good judgment and display personal initiative in all areas assigned.

Proficiency with Microsoft Office and Teams.

Working Conditions

Flexible hybrid position based in the Washington, DC area.

Essential functions are typically performed in an office setting with a low level of noise.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

NORD is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.