About the Company
The FDA Law Solution, LLC is a premier boutique legal advisory firm specializing in the complex regulatory landscape of the Food and Drug Administration. Led by industry veteran Ricky Benjamin, the firm provides sophisticated, commercially-grounded counsel to life sciences and healthcare companies. We bridge the gap between rigorous FDA regulations and business innovation through high-stakes advocacy and strategic foresight.
Our culture thrives on a blend of academic rigor, precision, and relentless client dedication. As a boutique firm, we offer a high-touch environment where senior expertise is directly accessible, fostering a culture of mentorship and professional development. We value integrity and specialized expertise in every legal solution we deliver to our global clientele.
Position Summary
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.
Core 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
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
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
The following qualifications are essential for success in this high-stakes regulatory environment. Candidates must demonstrate high "Big Law" brain power and the ability to operate with extreme precision.
- 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
These additional qualifications will help a candidate stand out and contribute to the specialized boutique nature of our firm.
- 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
Work Environment and 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 and Benefits
Competitive compensation and benefit package based on candidate's experience level.
Culture and Expectations
Successful employees at The FDA Law Solution must demonstrate a commitment to the firm's growth and the Founder's vision. We seek professionals who are smart, resourceful, and capable of working without ego in a high-stakes environment.
- 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 and Development Opportunities
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.
How to Apply
Submit your resume and a brief professional summary highlighting your FDA regulatory experience. Qualified candidates will be contacted for an initial interview. We are targeting a start date between April 1st and May 1st.
Pay: $85,000.00 - $120,000.00 per year
Benefits:
- 401(k)
- Health insurance
- Paid time off
Application Question(s):
- Do you have a Juris Doctor (JD) and are you in good standing with a U.S. bar?
Experience:
- FDA Regulatory Law: 5 years (Required)
Ability to Commute:
- Atlanta, GA 30309 (Required)
Work Location: In person
