FDA Regulatory Associate Attorney

A law firm seeks an experienced Associate Attorney with 2 to 4 years of experience in FDA regulatory law to join its growing team in Washington, D.C. The ideal candidate will have a strong foundation in regulatory strategy and compliance issues related to FDA-regulated products. This role offers a collaborative and supportive environment, providing associates with the opportunity to directly engage with clients and work on high-stakes matters, including regulatory approvals, compliance, and government investigations.

Duties:

• Develop regulatory strategies to help clients obtain marketing authorization for FDA-regulated products.
• Lead meetings with FDA representatives on behalf of clients seeking product approval or addressing regulatory matters.
• Advise clients on regulatory compliance issues, including complaint handling, recalls, field actions, and promotional reviews.
• Conduct internal investigations and audits to assess clients' adherence to regulatory requirements.
• Respond to government inspections and guide clients through compliance matters with federal agencies.
• Assist with due diligence for transactions, mergers, and securities offerings involving FDA-regulated entities.
• Draft and review complex legal documents, including regulatory filings, policies, and compliance protocols.
• Build and maintain strong client relationships by providing sound legal advice on FDA-related matters.

Requirements:

• 2 to 4 years of experience practicing FDA regulatory law, with a focus on compliance and product approval processes.
• Experience working with medical device regulatory issues is a plus.
• Strong written and verbal communication skills, with the ability to articulate complex legal concepts clearly.
• Ability to work independently while contributing effectively to team projects.
• Experience in conducting internal audits and responding to government inspections.
• Solid background in regulatory strategy, product marketing authorizations, and FDA interactions.
• Must be a member of the District of Columbia Bar or eligible to waive in.

Education:

• Juris Doctorate (JD) from an accredited law school.

Certifications:

• Active membership in the District of Columbia Bar or eligibility to waive in.

Skills:

• In-depth knowledge of FDA regulatory requirements, including approval processes and compliance issues.
• Strong research and writing abilities for drafting complex legal documents.
• Experience in conducting due diligence for transactions and regulatory compliance matters.
• Ability to manage client relationships and communicate effectively with both clients and regulatory agencies.
• Proficiency in handling FDA inspections, audits, and government inquiries.
• Ability to work in a collaborative environment and provide proactive solutions to regulatory challenges.

Benefits:

• Competitive compensation package based on experience.
• Opportunity to work closely with clients and contribute to high-profile regulatory matters.
• Collaborative, boutique firm environment with substantial client interaction and professional development opportunities.
• Health insurance options and other benefits as provided by the firm.

This is an exciting opportunity for an associate looking to build a career in FDA regulatory law within a supportive and dynamic team. If you have experience in regulatory compliance and FDA law, and you’re looking for a firm where you can make a tangible impact, we encourage you to apply.

The corporate law office is based in the District of Columbia. Areas of concentration are food and drug law. The law firm employs thirty-eight knowledgeable attorneys. Practice areas are significant. A few of their practice disciplines include new drug development, controlled substances, advertising and health care law. Attorneys are involved in various industry seminars, conferences and other law practice events throughout the year.