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A nationally recognized boutique law firm focused exclusively on healthcare and life sciences is seeking an experienced FDA Attorney to join its growing regulatory practice.
This Jobot Job is hosted by: Kendall Barnett
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Salary: $250,000 - $400,000 per year
A bit about us:
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Senior FDA Attorney
Counsel or Senior Counsel | New Jersey, New York or Fully Remote
A nationally recognized boutique law firm focused exclusively on healthcare and life sciences is seeking an experienced FDA Attorney to join its growing regulatory practice.
This is a senior-level opportunity for an attorney with at least 10 years of substantive FDA experience who is prepared to advise clients on sophisticated regulatory, compliance, transactional, and enforcement matters involving pharmaceuticals, compounding pharmacies, drug and device manufacturers, clinical trials, dietary supplements, veterinary products, and other FDA-regulated businesses.
The firm maintains a highly active FDA practice and receives an average of approximately five new FDA-related client inquiries each week. The successful candidate will inherit access to a strong existing pipeline of matters and will have the opportunity to play a meaningful role in the continued development and expansion of the practice.
The role may be based in the firm’s Pine Brook, New Jersey or New York City office. A fully remote arrangement may also be considered for an attorney located in another state.
Why join us?
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Why Consider This Opportunity?
The firm is focused exclusively on healthcare and life sciences and represents clients across the full healthcare ecosystem, including pharmacies, physician groups, hospitals, ambulatory surgery centers, laboratories, manufacturers, suppliers, ancillary service providers, and emerging healthcare businesses.
This position offers:
An established and consistently active pipeline of FDA matters.
An average of approximately five new FDA client inquiries each week.
The ability to join at the Counsel level or above, depending on experience.
Substantial autonomy and direct responsibility for sophisticated client matters.
Exposure to pharmaceutical compounding, manufacturing, clinical research, drug supply chain, devices, supplements, veterinary products, and enforcement.
Opportunities to shape and grow a nationally focused FDA practice.
Direct access to firm leadership and attorneys across complementary healthcare, pharmacy, transactional, intellectual property, and litigation practices.
Significant client contact and visibility within the life sciences industry.
Strong salary-growth potential based on performance, contributions, and practice development.
Hybrid flexibility for attorneys near the Pine Brook or New York City offices.
Potential for a fully remote arrangement for attorneys located in other states.
A collaborative and entrepreneurial environment that values initiative, subject-matter expertise, and long-term growth.
Compensation
The anticipated base salary range is $250,000–$350,000, depending on experience, qualifications, regulatory depth, location, and other job-related factors.
Additional compensation may include a performance-based bonus and substantial salary-growth potential based on the attorney’s contributions to the firm and practice.
Benefits
The firm offers a comprehensive benefits package that includes:
Paid time off
Medical coverage
Dental coverage
Vision coverage
401(k), upon eligibility
Hybrid work flexibility
Potential fully remote arrangements
Access to an on-site gym for employees based in the Pine Brook office
Opportunities for meaningful compensation progression and long-term professional growth
Job Details
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Key Responsibilities
Responsibilities will be tailored to the attorney’s specific background and may include advising clients in several or all of the following areas:
Pharmaceutical Compounding
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.
Drug Supply Chain and DSCSA Compliance
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.
Drug and Medical Device Manufacturing
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.
Clinical Trials and Research
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.
Labeling, Advertising and Promotion
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.
FDA Registration, Inspections and Enforcement
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.
Product Withdrawals, Recalls and Market Actions
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.
Importation and Exportation
Advise clients on FDA import and export requirements involving drugs, devices, ingredients, supplements, and other regulated products.
Counsel clients on detention, refusal, import alerts, admissibility, prior notice, and supply-chain documentation.
Assist companies responding to government inquiries and enforcement actions involving imported products or ingredients.
Additional Regulatory Areas
Advise clients on veterinary drugs, veterinary medical products, and veterinary compounding.
Counsel dietary-supplement companies regarding ingredients, claims, labeling, manufacturing, adverse-event reporting, and enforcement.
Advise medical-device companies throughout product development, clearance, registration, commercialization, inspection, and post-market compliance.
Analyze scientific and clinical literature to support regulatory submissions, enforcement responses, compliance strategies, and client counseling.
Assist with FDA-related due diligence and risk analysis in mergers, acquisitions, investments, licensing arrangements, and other commercial transactions.
Qualifications
At least 10 years of substantive FDA regulatory experience.
Private-practice law firm experience is strongly preferred, although highly qualified in-house candidates will also be considered.
Significant experience advising clients across multiple FDA-regulated product categories.
Experience performing most or all of the substantive responsibilities outlined above.
Deep familiarity with pharmaceutical compounding requirements, including Sections 503A and 503B, is strongly valued.
Experience with drug supply chain, manufacturing, FDA inspection, enforcement, labeling, advertising, or product recall matters.
Clinical-trial counseling and agreement-drafting experience is a plus.
Experience filing or advising on copyright matters is helpful.
Patent filing or related intellectual property experience is also beneficial.
Ability to independently manage sophisticated regulatory matters and communicate directly with clients and government agencies.
Excellent legal research, analytical, drafting, negotiation, and communication skills.
Ability to analyze scientific, clinical, manufacturing, and technical information.
Strong business judgment and the ability to provide practical, commercially informed advice.
Collaborative, team-oriented approach and the ability to work cohesively with attorneys across multiple disciplines.
Strong work ethic, responsiveness, and commitment to exceptional client service.
Admission to practice law in at least one U.S. jurisdiction is required.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
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