Associate - Pharmacy

Description:

• Advise clients on FDA regulatory matters impacting pharmacy and pharmaceutical sectors, including compliance with FDA guidelines, labeling, advertising, and promotional requirements.
• Provide guidance on federal and state laws governing pharmacy operations, drug development, and distribution.
• Assist clients through FDA approval processes, including new drug applications, compliance audits, and post-market surveillance.
• Draft, review, and negotiate agreements related to pharmaceutical manufacturing, distribution, and consulting.
• Conduct legal research and analysis on regulatory issues and provide strategic recommendations to clients.
• Represent clients in interactions with the FDA and other regulatory bodies on compliance and enforcement issues.
• Collaborate with colleagues across practice areas to provide comprehensive legal solutions for pharmaceutical and pharmacy-related regulatory matters.

• Juris Doctor (JD) degree from an accredited law school.
• Admission to the DC bar or eligibility to waive in.
• 3-6 years of experience in FDA regulatory and pharmacy law, preferably in a law firm.
• Experience advising on pharmacy operations, drug compounding, regulatory compliance, and state licensing requirements.
• Experience advising on pharmacy operations, regulatory compliance, and related pharmaceutical agreements.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.
• Strong interpersonal skills and the ability to work effectively in a team-oriented environment.

• The expected annual salary for this position ranges from $245,000 to $345,000, determined by factors including experience, education, and relevant skills.
• Associates also participate in a performance and hours-based bonus program.
• Comprehensive healthcare benefits, including health, dental, and vision insurance.
• Generous paid time off (PTO) and holidays.
• 401(k) plan with employer matching contributions.
• Continuing legal education (CLE) and professional development opportunities.
• Opportunities for pro bono work.