Qualifications

• 3+ years of experience at the FDA is essential.
• Proficiency in contract research and management tracking tools required.
• Detail-oriented with strong diplomacy in communication.
• Excellent research and writing skills are a must.
• Advanced proficiency in PowerPoint, Excel, and related software is needed.

Responsibilities

• Build and maintain FDA contact relationships.
• Collaborate with program managers and FDA contacts for program support.
• Assist in ensuring regulatory consultants support program managers.
• Identify key programs and points of contact within USG agencies.
• Use Intergovernmental tracking system to capture data and maintain engagement dashboards.
• Draft engagement reports and summarize potential opportunities.
• Create agency-specific presentations to support outreach efforts.

Benefits

• Opportunity to engage directly with FDA and government agencies.
• Chance to support and shape regulatory program activities.
• Collaborative work environment with experienced professionals.
• Opportunities for professional development in regulatory affairs.