Senior Regulatory Associate — Drugs & Biologics

About the Company

The FDA Law Solution, LLC is a premier legal advisory firm specializing in navigating the complex regulatory landscape of the Food and Drug Administration. Led by industry veteran Ricky C. Benjamin, the firm provides strategic counsel to life sciences and healthcare companies to ensure product compliance and successful market entry. We operate with a boutique feel where senior expertise is directly accessible, fostering a culture of mentorship, academic rigor, and relentless client dedication.

Responsibilities

• Support strategy for FDA, FTC, USDA, EPA, IND, NDA, and BLA development and commercialization programs
• Execute rare disease regulatory strategies including orphan drug designations
• Provide technical counsel on GLP-1 compounding and USP requirements
• Manage inspection readiness and draft responses to FDA 483s
• Draft high-level regulatory analyses and strategic client guidance memos
• Manage promotional and labeling review for FDA and FTC compliance
• Facilitate PRC and MLR meetings with minimal senior oversight
• Monitor post-market compliance and adverse event reporting requirements
• Conduct regulatory due diligence for life science transactions and acquisitions
• Draft formal responses to FDA Warning Letters and enforcement actions
• Coordinate directly with client Regulatory Affairs, Quality, and Marketing departments
• Manage multiple high-priority client matters independently and efficiently
• Participate in team meetings to align legal strategy with business goals
• Communicate complex regulatory concepts to non-legal client stakeholders
• Maintain professional relationships with FDA project managers and officials

Qualifications

Required Qualifications

• Juris Doctor (JD) degree and active bar membership in good standing
• 5+ years of dedicated FDA regulatory law experience
• Proven track record in any of: FDA, FTC, USDA, EPA, IND, NDA, and BLA submission strategies
• Expert-level legal writing, issue spotting, and regulatory analysis skills
• Strong scientific literacy for engagement with technical and clinical data

Preferred Qualifications

• Experience with GLP-1 compounding (503B) and USP 797/795 standards
• Technical proficiency with Veeva PromoMats for promotional review
• Prior experience securing orphan drug designations for rare diseases
• Familiarity with REMS programs and market exclusivity strategies
• History of high billable efficiency with minimal time write-offs

Environment

This position is based onsite at our Atlanta, GA office. Standard business hours apply with occasional deadline-driven intensity. Collaborative environment requiring frequent face-to-face engagement with the Founder. Occasional travel may be required for client site visits or inspections.

Compensation

Competitive compensation and benefit package based on candidate's experience level.

Culture

• Demonstrate absolute accountability and ownership over client deliverables
• Maintain a solution-oriented mindset when navigating complex regulatory barriers
• Exhibit professional resilience and reliability under tight agency deadlines
• Practice clear, respectful, and proactive communication with internal teams
• Align with the firm's dedication to precision and protective advocacy

Growth & Development

This role offers a unique path to senior leadership through direct mentorship from the firm's Founder and CEO. You will gain exposure to cutting-edge specialty regulatory areas that are often unavailable in larger firm settings. We encourage internal advancement for associates who demonstrate business savvy and a commitment to expanding the firm's influence and client base.