Senior Regulatory Associate — Drugs & Biologics

About 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 Regulatory Strategy and Development 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 Drafting high-level regulatory analyses and strategic client guidance memos Responsibilities Compliance and Promotional Review 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 Responsibilities Cross-Functional Collaboration 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 Work Environment & Schedule 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 Salary & Benefits Competitive compensation and benefit package based on candidate's experience level. Culture Culture & Expectations 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 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. Ready to Apply? Submit your resume and cover letter highlighting your FDA regulatory experience. Apply Now