Senior Director, Regulatory Affairs

The Healthcare Distribution Alliance (HDA) is the national organization representing primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Our members include 35 national, regional and specialty primary distribution companies who are not just distributors, but are technology innovators, information management experts, security specialists and efficiency professionals. Their expertise streamlines the supply chain to ensure safety and efficiency, while also achieving cost savings for our nation’s healthcare system.

Additionally, the HDA Research Foundation, HDA’s nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

Job Summary:

This full-time, local staff position will direct HDA regulatory activities, with primary (though not exclusive) emphasis on FDA matters. You will manage the research, analysis, policy development and reporting of regulatory activities that relate to present and future HDA membership interests, act as a primary federal agency liaison and advocate on regulatory issues. You will recommend policies and positions on federal regulatory proposals and facilitate and coordinate members' efforts to implement them.

Position Responsibilities:

·        Analyze, develop for Board approval and direct the association's positions on regulatory and related activities bearing upon the HDA membership.

·        Direct the analysis of applicable federal regulatory proposals and related initiatives for their merit and effect upon the HDA membership.

·        Manage and serve as primary staff leader on the Regulatory Issues Task Force (RITF), and the Traceability Implementation Work Group (TIWG), ensuring that the agenda and schedules are coordinated with appropriate participants.

·        Serve as lead HDA representative in regulatory hearings and review proceedings and other related activities to gather information and participate when indicated and/or attend and monitor as needed.

·        Manage the writing, editing and production of manuals and other publications regarding regulatory issues affecting the HDA membership.

Qualifications:

·        College degree (BA or BS) required. Advanced degree highly desired.

·        Ten years’ experience in a regulatory affairs position (private sector and/or government) in a healthcare-related field.

·        Strong analytical, verbal and written communication skills.

·        Career accomplishments must document sound business judgment, management skills and ability to interact with senior executives and members of federal regulatory agencies.

·        Extensive understanding of the federal regulatory process.

·        Established working relationships with critical federal agencies.

·        Must be willing to travel (10%) throughout the year.

·        This is a local hybrid position; individual must commit to at least two in-person office days in HDA’s Washington, D.C., headquarters.

Contact:

First impressions matter in our hiring process, so please email a cover letter highlighting your qualifications for this position and salary requirements, along with your resume, to HRQ1@hda.org. 

HDA is proud to be an Equal Opportunity Employer. We believe that diversity of background and perspective are strengths, and seek to continue to grow a diverse, highly committed, skilled and collaborative staff. We encourage candidates from various backgrounds to apply.