TITLE: FDA REGULATORY ATTORNEY
Firm X is seeking an experienced FDA Regulatory Attorney to join its growing FDA and Life Sciences practice. Due to significant client demand and a steady influx of new FDA-related matters, we are looking for an attorney with deep regulatory experience advising pharmaceutical, compounding, medical device, biotechnology, healthcare, and related life sciences clients.
Key Responsibilities:
- Advise clients on FDA regulatory compliance matters involving drugs, biologics, medical devices, dietary supplements, and compounding pharmacies.
- Counsel clients regarding FDA regulations, guidance, inspections, investigations, warning letters, and enforcement actions.
- Provide guidance on:
- Compounding (503A and 503B)
- Drug Supply Chain Security Act (DSCSA)
- cGMP compliance
- Drug and device manufacturing requirements
- FDA registrations and annual filings
- Labeling, marketing, and advertising reviews
- Product recalls and withdrawals
- Import/export compliance
- Veterinary medicine and veterinary compounding
- Assist with NDA, ANDA, 510(k), PMA, OTC, and other FDA submissions.
- Advise clients regarding clinical trial compliance, research agreements, informed consent forms, IRB requirements, and related regulatory matters.
- Review scientific and clinical literature to support regulatory strategies and client guidance.
Qualifications:
- J.D. from an accredited law school.
- Licensed and in good standing in at least one U.S. jurisdiction.
- 10+ years of FDA regulatory experience.
- Prior law firm experience strongly preferred; exceptional in-house FDA counsel will also be considered.
- Strong working knowledge of pharmaceutical, medical device, compounding, and healthcare regulatory frameworks.
- Experience with FDA inspections, 483 responses, warning letters, and compliance programs preferred.
- Clinical trial experience is a plus.
- Patent and/or copyright filing experience is a plus.
- Excellent drafting, analytical, and client counseling skills.
Company Description
About The Rockridge Group:
TRG is a privately held Limited Liability Company committed to connecting businesses with job seekers. We deliver high quality contingent personnel to our clients using our 3-step collaborative engagement model:
Collaborate. We partner with you to understand the unique needs of your business before we propose a solution.
Strategize. Based on your goals and staffing challenges, we develop high impact solutions designed for your industry.
Engage. We work with your team before, during, and after every engagement to deliver 100% satisfaction.
With over ten (10) years experience in the resource solutions sector, principals Greg Donner [link to bio] and Ronald Lom [link to bio] leverage the power of strategic partnership to create a powerful staffing model that improves your quality of hire.