Senior Regulatory Associate — Drugs & Biologics

Atlanta, GA (On-Site)Full-TimeReports to: Founder & CEO

The Senior Regulatory Associate serves as a critical strategic advisor focusing on defensible counsel for drug and biologic matters. This role supports the organization by managing high-priority client matters involving product development programs regulated by agencies such as the FDA, FTC, USDA, and EPA, including IND, NDA, and BLA pathways. The ideal candidate is a high-achieving legal professional who balances technical scientific literacy with elite legal writing and project management skills.

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

Qualifications

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