Location: Washington, D.C. / Flexible / Hybrid / Remote (as applicable)
Position Overview
Our client is seeking a partner-level FDA Regulatory Attorney to join and help grow its Life Sciences practice. This is a rare opportunity to step into a platform built for attorneys who want more — more autonomy, better economics, and a culture that actually delivers on what it promises.
The right candidate brings a portable book of business ($500K+), deep FDA regulatory expertise, and a desire to build something meaningful within a firm that is deliberately structured as an alternative to large, bureaucratic Am Law firms. You will work alongside a nationally recognized FDA/IP partner with over three decades of experience, playing a central role in expanding the firm’s growing FDA and life sciences footprint.
Why Our Client
- Real Autonomy. Compared to most Am Law 200 firms, attorneys here have measurably more control over how they build and run their practices without the overhead of centralized bureaucracy.
- Superior Economics. The firm’s model is designed to reward rainmakers. Compensation structures are competitive, transparent, and built to attract attorneys who generate business.
- Culture That Is Lived. Our client prides itself on all-star legal talent without the all-star attitudes. This isn’t a tagline — it’s reflected in how attorneys collaborate, share resources, and support each other’s practices.
- Active Growth Focus. The firm is specifically investing in growing its FDA practice. You won’t be joining a mature, settled group you’ll be helping shape what it becomes.
- National Platform, Boutique Feel. With 35+ Life Sciences professionals across offices from D.C. to Silicon Valley, the firm offers real breadth without losing the entrepreneurial energy that makes partner-level work satisfying.
Practice Context
Our client’s Life Sciences group covers the full regulatory and IP spectrum, anchored by an FDA Pharmaceutical and Biologics Market Team based in Washington, D.C. The practice lead brings over three decades of regulatory experience including nine years as regulatory counsel at the FDA Office of the Commissioner and the Center for Drug Evaluation and Research and has built a practice spanning drug and biologic approvals, Hatch-Waxman litigation, REMS, medical devices, and emerging areas including AI-enabled products and cannabis-derived therapeutics.
The team is deliberately small and high-caliber, working with pharmaceutical companies, biotech startups, medical device makers, and FDA-regulated manufacturers at all stages of the product life cycle — from pre-IND strategy through commercialization, enforcement, and litigation.
Key Responsibilities
- Serve as strategic FDA regulatory counsel to pharmaceutical, biotech, medical device, and life sciences clients
- Advise on regulatory pathways, approval strategies, and pre-market submissions including INDs, NDAs, BLAs, ANDAs, 510(k)s, and PMAs
- Support 505(b)(2) strategies, biosimilar applications, REMS, and combination product development
- Represent clients in FDA meetings and engagements; draft citizen petitions, comments, and regulatory correspondence
- Integrate FDA regulatory strategy with patent and IP considerations across product life cycles
- Advise on Hatch-Waxman and BPCIA matters, including litigation support and exclusivity strategy
- Counsel on emerging areas such as AI-enabled products, regenerative medicine, cannabis/psychedelics, dietary supplements, and cosmetics as applicable
- Help develop and expand the firm’s FDA practice through client development, thought leadership, and internal collaboration
Qualifications
- J.D. from an accredited law school; active bar admission in D.C., Maryland, New York, or another relevant jurisdiction
- Minimum 8+ years of FDA regulatory legal experience in a law firm, government agency (including FDA), or in-house role
- Demonstrated experience advising on FDA pre-market submissions, clinical development, regulatory strategy, and/or Hatch-Waxman matters
- Portable book of business of $500,000 or more, or a credible near-term path to that threshold
- USPTO admission and/or scientific/technical background is a meaningful plus but not required
- Strong written and oral advocacy skills; ability to operate independently and as a collaborative team member
- A desire to build not just sustain within a growing, entrepreneurially-minded platform
Compensation & Benefits
Our client offers highly competitive partner-level compensation commensurate with experience and book of business, structured to reward business generation and client service. The firm provides a comprehensive benefits package including:
- Medical, dental, and vision coverage
- Federal and state leave programs as required by applicable regulations
- Additional benefits designed to support professional growth and work-life balance
Location is flexible; Washington, D.C. is the natural home for this practice but the firm supports hybrid and remote arrangements as appropriate.