Description:

Build your big career with the Firm that does Big Law better. An International Law Firm is a leading global law firm that brings together more than 1,400 lawyers and 1,200 business professionals. We celebrate excellence, collaboration and community and have been recognized as a top workplace by The American Lawyer, Working Mother Magazine, Vault and the Human Rights Campaign.

At An International Law Firm, we don't just invest in your future, we accelerate your career – wherever it may lead. That includes supporting you both in and outside of the office, with our attorneys receiving personalized guidance, structured mentorship and confidential career coaching.

With us, you'll find:
  • A Firm where everyone belongs: Our award-winning culture prioritizes warmth and authenticity — we encourage you to be yourself!
  • Enthusiasm for diverse perspectives: We're smarter and stronger when everyone has a voice and a seat at the table. We welcome unique viewpoints and ideas, and we make opportunities for you and your career to thrive.
  • Support to feel your best and do your best: Wellness is integral to building a successful career and a rich life. That's why our benefits program supports your physical, emotional, mental and financial health, with an emphasis on work/life balance. We're proud to be the first firm to offer billable hours for wellness.
  • Real rewards for real work: We offer generous compensation packages that recognize hard work and excellence. Our individual merit-based system enabled 65% of our associates to earn above the Cravath scale in 2023.
  • The Healthcare Practice Group is seeking an FDA Associate with 4-5 years of experience and a strong background in drug and medical device regulatory compliance issues, particularly in current good manufacturing practice (CGMP) matters to join our Washington, DC office. Our FDA practice works in partnership with companies and investors across the complete ecosystem of FDA-regulated products—drugs, devices, health technologies, biologics, food, cosmetics and cannabis. The ideal candidate will have prior industry experience counseling biopharma companies in all stages of development or a scientific background in analytical chemistry, chemical engineering, or microbiology. Experience at the Food and Drug Administration is a plus. Applications should be submitted via our web apply portal. Questions can be directed to Amy Gillmore, Lateral Associate Recruiting Manager, at agillmore@mwe.com

Duties:
  • Provide legal advice and support on FDA regulatory matters related to drug and medical device compliance.
  • Conduct legal research and analysis on current good manufacturing practice (CGMP) issues and other FDA regulations.
  • Draft and review legal documents, including regulatory submissions, compliance policies, and contracts.
  • Collaborate with internal teams and clients to develop regulatory strategies and ensure compliance with FDA requirements.
  • Represent clients in FDA inspections, investigations, and enforcement actions.
  • Stay updated on developments in FDA regulations and industry trends.

Requirements:
  • 4-5 years of experience in FDA regulatory compliance, preferably in a law firm or corporate setting.
  • Strong understanding of FDA regulations matters, particularly in current good manufacturing practice (CGMP).
  • Prior industry experience in pharmaceutical manufacturing or a scientific background in analytical chemistry, chemical engineering, or microbiology is strongly preferred.
  • Experience at the Food and Drug Administration is a plus.
  • Exceptional analytical and problem-solving abilities.
  • Excellent written and verbal communication skills, along with a strong academic background.
  • Ability to work effectively in a fast-paced environment and handle multiple tasks simultaneously.
  • Strong attention to detail and accuracy.
  • Must be barred in the District of Columbia, or eligible for admission through reciprocity or UBE score transfer.