FDA Regulatory Specialist/Analyst

General

• Regularly participating in Healthcare and FDA (including sub-group) team meetings
• Monitoring and analysis of FDA regulatory developments
• Researching and synthesizing FDA regulatory requirements and expectations
• Attend FDA Public Meetings, webinars or other informational events and prepare summaries
• Direct contact and interaction with clients
• Direct communication with FDA
• Facilitating knowledge management for the FDA practice
• Assisting in responding to requests for proposals and budgets
• Assisting with the drafting of RFPs, business development initiatives, and FDA marketing documents
• Organizing client files (P-drive, FTP sites, other internal file sharing sites, binders)

FDA Regulatory

• Reviewing and drafting summaries of FDA Guidance documents, FDA policy statements or other FDA documents reflecting FDA’s current thinking
• Reviewing public dockets related to proposed regulations or new of modified Guidance documents
• Monitoring industry developments that relate to client issues
• Drafting brief, same-day, client-ready summaries of FDA developments
• Assisting with the development of regulatory filings and electronic submissions

FDA Compliance and Enforcement

• Monitoring, reviewing and summarizing new compliance and enforcement initiatives from FDA
• Assisting the team in developing client advisories on new and emerging issues
• Reviewing client documents for compliance assessment and investigation purposes
• Reviewing and synthesizing information stemming from recent trends in FDA Warning Letters 
• Assisting with electronic filings made on behalf of clients to FDA (including, at time, nights and weekends)
• Assisting with compilation of complex responses to FDA, including reviewing and inputting edits from various authors (client or internal) into a central, controlled document
• Reviewing and assembling exhibits, attachments or evidence to support submissions to FDA
• Maintaining client filing calendars

Skills Need to be Successful

• Ability to establish and maintain effective working relationships within the practice group, with partners and associates, and with clients
• Understanding of the basic workings of the U.S. Food and Drug Administration, including the ability to quickly and efficiently navigate FDA’s webpage
• Familiarity with, or ability to become familiar with, FDA systems and tools for regulatory and data submissions
• Familiarity with the federal regulatory process, comment periods, and federal agency jurisdiction and organizational charts
• Strong writing skills with a thorough command of the English language to include excellent spelling, grammar and punctuation
• Ability to accurately and quickly edit written materials
• Strong organizational skills, with ability to prioritize numerous tasks and complete them properly under time constraints
• Strong computer skills, including the ability to master applications that are specific to Alston & Bird
• Proven keen attention to detail
• Ability to work at the direction of multiple attorneys
• Ability to work independently
• Two + years of experience in government, preferably at FDA preferred