FDA and Pharmaceutical Regulatory Attorney

Verrus; United States; On-site; USD 180,000 - 300,000; Full time

Benefits offered by this job

Competitive compensation

National office network across the U.S

Job summary

Verrus seeks an FDA and Pharmaceutical Regulatory Attorney to advise pharmaceutical, pharmacy, compounding, and healthcare clients on regulatory compliance and commercial strategy across the U.S. This attorney will work on Sections 503A/503B matters, guidance on regulatory pathways, and support corporate transactions within a fast-paced national practice.

The ideal candidate has substantive FDA and life sciences regulatory experience, strong drafting skills, and the ability to manage

Qualifications

• Substantive FDA, pharmaceutical, pharmacy, or life sciences regulatory experience.
• Strong knowledge of the FDA regulatory framework and the FDC Act.
• Experience advising on FDA compliance, regulatory strategy, enforcement, or government interactions.
• Experience with pharmaceutical compounding and state pharmacy regulation is valuable.
• Ability to manage sophisticated matters independently with practical, commercially focused advice.
• Strong drafting, analytical, client-management, and communication skills.
• Experience in a law firm within a fast-paced national practice.

Responsibilities

• Advising pharmaceutical, pharmacy, compounding, and healthcare clients on FDA regulatory compliance and commercial strategy.
• Counselling clients on prescription drugs, biologics, compounded products, and regulated therapies.
• Advising on Sections 503A/503B and state pharmacy regulation.
• Guiding on regulatory pathways, product classification, and essential restrictions.
• Advising on pharmacy operations and state licensing requirements.
• Supporting clients during FDA inspections, investigations, and enforcement actions.
• Reviewing advertising and patient communications for regulatory compliance.
• Drafting and negotiating supply, distribution, manufacturing, licensing, and clinical trial agreements.
• Providing regulatory support for corporate transactions and due diligence.
• Developing direct client relationships and drive matters with partner oversight.

Skills

FDA regulatory

Pharmaceutical regulatory

Regulatory strategy

Client management

Legal drafting

Independent work

Communications

Education

Bar admission (US state)

Juris Doctor (JD)

Job description

FDA and Pharmaceutical Regulatory Attorney

Location:

Any of the firm’s offices across the U.S.

Competitive compensation dependent on qualifications and experience

About the Firm:

A leading national AmLaw 100 firm with an established FDA, healthcare, and life sciences regulatory platform. The practice represents pharmaceutical manufacturers, pharmacies, outsourcing facilities, healthcare providers, telehealth businesses, and other companies operating throughout the pharmaceutical supply chain.

The firm is expanding its capabilities across pharmaceutical regulation, pharmacy law, compounding, enforcement, and commercial counselling. This opportunity would suit an attorney who can provide technically strong, commercially practical advice while taking meaningful ownership of sophisticated client matters.

Responsibilities:

• Advising pharmaceutical, pharmacy, compounding, and healthcare clients on FDA regulatory compliance and commercial strategy.
• Counselling clients on matters involving prescription drugs, biologics, compounded products, GLP-1 products, peptides, hormones, ketamine, and other regulated therapies.
• Advising traditional pharmacies and outsourcing facilities on Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
• Providing guidance on product classification, regulatory pathways, bulk drug substance sourcing, wholesaling, anticipatory compounding, and “essentially a copy” restrictions.
• Advising on pharmacy operations, state licensing requirements, and interactions with state boards of pharmacy.
• Supporting clients during FDA inspections, investigations, warning letters, enforcement actions, litigation, and other regulatory disputes.
• Reviewing advertising, promotional materials, telehealth arrangements, and patient-facing communications for regulatory compliance.
• Drafting and negotiating supply, distribution, manufacturing, licensing, clinical trial, and other commercial agreements.
• Providing regulatory support for corporate transactions, investments, due diligence, and strategic partnerships.
• Developing direct client relationships and managing matters with appropriate partner oversight.

Candidate Requirements:

• Substantive FDA, pharmaceutical, pharmacy, or life sciences regulatory experience.
• Strong knowledge of the Federal Food, Drug, and Cosmetic Act and the regulatory framework governing pharmaceutical products.
• Experience advising clients on FDA compliance, regulatory strategy, enforcement, or interactions with government agencies.
• Experience involving pharmaceutical compounding, Sections 503A and 503B, or state pharmacy regulation would be particularly valuable.
• Ability to manage sophisticated matters independently and provide practical, commercially focused advice.
• Strong drafting, analytical, client-management, and communication skills.
• Experience gained within a law firm and the ability to operate effectively within a fast-paced national practice.

Certifications:

• Active admission to at least one U.S. state bar.

Benefits of the Firm:

• Opportunity to work from any of the firm’s offices across the U.S.
• Access to sophisticated pharmaceutical, pharmacy, healthcare, and life sciences clients.
• A varied practice encompassing regulatory counselling, enforcement, litigation, transactions, and commercial agreements.
• Significant responsibility, direct client contact, and the opportunity to manage matters independently.
• Support from a broader national platform with substantial transactional, litigation, and regulatory capabilities.
• Competitive compensation and strong long-term career-development opportunities.
• A collaborative environment in which attorneys can help shape the continued growth of the practice.