Senior FDA Attorney

Senior FDA Attorney

Experience: Senior Level

Salary: $250,000 - $400,000 per year

• Advise pharmacies, outsourcing facilities, manufacturers, suppliers, and related businesses on federal compounding laws, regulations, and FDA guidance.
• Counsel clients regarding Section 503A traditional pharmacy compounding requirements.
• Advise Section 503B outsourcing facilities on registration, reporting, manufacturing, labeling, inspection, and compliance obligations.
• Counsel bulk active pharmaceutical ingredient suppliers, repackagers, wholesalers, and other participants in the compounded-drug supply chain.
• Assist clients responding to FDA audits, inspections, investigations, warning letters, and enforcement actions involving compounded products.
• Advise on interstate distribution, office-use compounding, patient-specific prescription requirements, bulk drug substance restrictions, and related state and federal issues.

• Advise clients on Drug Supply Chain Security Act requirements and evolving track-and-trace obligations.
• Counsel manufacturers, repackagers, wholesale distributors, dispensers, third-party logistics providers, brokers, and other trading partners.
• Advise on authorized and unique trading-partner requirements.
• Counsel clients regarding serialization, interoperable electronic tracing, product identifiers, transaction data, verification, and suspect or illegitimate product investigations.
• Develop compliance strategies addressing operational and contractual drug-supply-chain risks.

• Advise drug, biologic, medical device, and related manufacturers regarding current good manufacturing practice requirements.
• Counsel clients on manufacturing controls, quality systems, validation, testing, documentation, deviation management, and corrective and preventive action.
• Advise on New Drug Applications and Abbreviated New Drug Applications, including filing strategy, regulatory evaluation, and compliance considerations.
• Counsel medical device companies regarding 510(k) submissions, premarket approval pathways, classification, registration, and listing.
• Advise on over-the-counter drug filings, monograph compliance, labeling, and commercialization.
• Review manufacturing practices and recommend strategies to reduce regulatory and enforcement risk.

• Advise sponsors, research organizations, investigators, healthcare providers, and other stakeholders on clinical-trial requirements.
• Structure and draft clinical trial agreements, master services agreements, informed consent forms, confidentiality agreements, data-use agreements, and related research contracts.
• Counsel clients on Institutional Review Board submissions, approvals, continuing review, and compliance.
• Advise on clinical trial design, study initiation, recruitment, data collection and use, adverse-event reporting, monitoring, and post-trial obligations.
• Address issues involving human-subject protection, informed consent, investigator responsibilities, and regulatory reporting.
• Review clinical literature and incorporate scientific findings into legal arguments, regulatory submissions, and client strategies.

• Review product labels, packaging, promotional materials, websites, social media, and advertising for FDA compliance.
• Advise on disease claims, structure-function claims, intended use, off-label promotion, substantiation, and comparative claims.
• Counsel clients on labeling changes, product positioning, and promotional-risk mitigation.
• Coordinate with advertising, intellectual property, healthcare, and litigation attorneys where claims raise overlapping legal concerns.

• Advise clients on establishment registration, product listing, annual reporting, and other recurring FDA filing obligations.
• Prepare clients for FDA inspections and assist with inspection readiness.
• Analyze Form FDA 483 observations and draft comprehensive responses.
• Respond to warning letters, untitled letters, import alerts, consent-decree risks, and other enforcement actions.
• Conduct internal reviews and investigations involving potential regulatory violations.
• Develop corrective-action plans, compliance policies, procedures, and employee training.
• Advise on voluntary disclosures and communications with FDA and other regulatory agencies.

• Advise clients regarding voluntary and mandatory recalls, market withdrawals, stock recoveries, and product corrections.
• Develop recall strategies and draft communications to regulators, distributors, providers, patients, and customers.
• Counsel clients on adverse-event reporting, health-hazard evaluations, root-cause analysis, and post-recall remediation.

• Advise clients on FDA import and export requirements involving drugs, devices, ingredients, supplements, and other regulated products.
• Counsel clients on detention,…