FDA Attorney

TITLE: FDA ATTORNEY POSITIION: DIRECT HIRE Firm X, established in 2000, is a national boutique law firm focused exclusively on Healthcare and Life Sciences. The Firm draws on its experience representing stakeholders across the entire healthcare spectrum. In the Life Sciences, Firm X, has represented pharmacies of all kinds and assisted with regulatory, transactional, and litigation matters. On the Healthcare side, the Firm's clients have included large physician group practices, hospitals, hospital medical staff, ambulatory surgery centers, laboratory companies, as well as the complete panoply of ancillary service providers. Firm X attorneys are licensed in numerous states. The Firm has offices in Pine Brook, New Jersey, and New York City. A Mid-Level or more senior FDA Attorney (Counsel-level or higher) is sought for Firm X’s Pine Brook, NJ, New York City, or fully remote office. They receive an average of 5 new FDA client inquiries per week. Responsibilities will align with the Attorney’s background, which should include: • Compounding rules, regulations and FDA guidance o 503A o 503B o Bulk API suppliers and repackagers o FDA audits/investigations • Drug supply chain security and track and trace o Trading partner requirements o Unique trading partners (i.e., 3PLs, brokers, etc.) o Serialization implementation requirements o Other drug supply chain considerations • Drug and device manufacturing rules o CGMP compliance o NDA and ANDA filings and evaluation o 510K Premarket Approval Filings and evaluation o OTC filings and evaluation o Advice on manufacturing practices • Clinical trial rules o Structuring and drafting clinical trial agreements, informed consent forms, master service agreements, and related research contracts o Institutional Review Board (IRB) submissions and compliance o Clinical trial design, study initiation, data use, adverse event reporting, and post-trial obligations • Labeling and advertising reviews • FDA registration and annual filings • FDA inspections, 483 responses and warning letters • Drug withdrawals and recalls • FDA importation and exportation rules • Veterinary medicine and veterinary compounding • Dietary supplements • FDA regulated medical devices • Reviews of clinical literature and incorporation into arguments/strategies (access to these clinical literature directories is a plus) Requirements: • 10+ years FDA experience – private law firm experience strongly preferred, but will also consider in-house candidates • Clinical trial experience a plus • Filing copyrights a plus • Filing patents a plus • May work in the Pine Brook or New York City office; will also consider fully remote arrangement if located in other states • Admitted to practice in at least one US state • Experience performing most/all of the job responsibilities of the position (outlined above) • Team-player mindset, and ability to work cohesively and collaboratively with a team of attorneys • Strong work ethic Benefits: Firm X offers a hybrid schedule, competitive salary, and a full range of benefits, including PTO, medical, dental, vision, 401(k) (upon eligibility to participate), on-site gym (Pine Brook), and opportunities for substantial salary progression based on performance and contributions. *The posted salary will depend on years of experience and other factors.