Remote attorney Or Senior attorney

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.

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 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 firms Pine Brook, New Jersey or New York City office. A fully remote arrangement may also be considered for an attorney located in another state.

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.

An established and consistently active pipeline of FDA matters.

Exposure to pharmaceutical compounding, manufacturing, clinical research, drug supply chain, devices, supplements, veterinary products, and enforcement.

Direct access to firm leadership and attorneys across complementary healthcare, pharmacy, transactional, intellectual property, and litigation practices.

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.

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 attorneys contributions to the firm and practice.

Medical coverage

Dental coverage

Hybrid work flexibility

Potential fully remote arrangements

Access to an on-site gym for employees based in the Pine Brook office

Responsibilities will be tailored to the attorneys 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.

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

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.

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.

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.

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.

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.

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.

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.

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.

Collaborative, team-oriented approach and the ability to work cohesively with attorneys across multiple disciplines.

Admission to practice law in at least one U.Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobots policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.

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