The Regulatory Affairs Manager monitors regulatory issues within designated areas and identifies opportunities to engage with government agencies including those within the Department of Health and Human Services (HHS) to further advance the mission and priorities of the Immune Deficiency Foundation (IDF). Working with the Chief Public Policy Officer, this position will draft responses to a prescribed set of regulatory and reimbursement-related issues and represent the organization before state and federal agencies. This position will represent the organization to the public and interact closely with other staff members, particularly those involved in patient services, research, and communications. This position will work virtually but must be located within commuting distance to Washington DC (DMV) and able to travel into DC for regular meetings.
Principal Duties And Responsibilities
- Monitor, analyze, and draft responses to a prescribed set of regulatory and reimbursement-related issues and represent IDF before state and federal agencies.
- Engage with the agencies, including but not limited to centers within the HHS such as, the Centers for Medicare and Medicaid Services (CMS), and Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), as well as state health departments, state Medicaid offices, and insurance commissions.
- Work on issues related to Medicare coverage determinations, Medicaid coverage and preferred drug list determinations, FDA drug development and safety policies, agency guidance policies related to patient engagement and diversity equity and inclusion (DEI) impacting health access, clinical trials, and research opportunities.
- Monitor regulatory issues in defined areas and identify opportunities to advance IDF’s priorities.
- Participate in patient advocacy coalitions focused on regulatory issues and recommend what issues IDF should engage in.
- Work with appropriate staff and partners to prepare regulatory comments and correspondence to state and federal agencies.
- Maintain and develop new relationships with federal agency staff and coalition partners.
- Serve as a resource to other advocacy staff on regulatory issues impacting legislative and payer issues.
- Support and collaborate with other policy team members.
- Attend virtual and in person advisory committee meetings, federal agency meetings, coalition meetings, issue briefings and hearings as necessary.
Qualifications
- Minimum of four (4) years of experience in and knowledge of regulatory affairs.
- Knowledge of federal executive branch procedures and policies.
- Knowledge of health care access issues and prior experience writing regulatory comment letters and interacting with policymakers.
- Ability to identify issues and opportunities in the regulatory environment that will help advance the mission of IDF.
- Excellent writing and oral communication skills and the ability to think analytically.
- Ability to operate with minimum supervision, take initiative, and produce results.
Technical Requirements:
- Must live within commuting distance from Washington, DC (DMV)
- Work virtually, but able and willing to attend meetings in the DC area on a weekly basis.
Proficiency in the following software programs is necessary for this role:
- Microsoft Office, including Word, Excel, PowerPoint, Outlook
- Internet Browsers (Firefox, Chrome, Internet Explorer)
- CRM software
- Enterprise resource planning ERP software
- Project management software
Education:
- Juris Doctorate or Master’s degree in Public Policy, Public Administration, Political Science or related field desirable or equivalent Experience.
- Experience working within a governmental agency focused on health or for a patient advocacy organization on regulatory matters.