Healthcare Associate - Washington DC
Our client, an AMLAW 100 firm, is seeking an FDA Associate with 4-5 years of experience to join their Healthcare Practice Group in Washington DC.
The estimated salary for this position is $310,000-$365,000 (annually) and may vary depending on experience and other factors.
Responsibilities:
- 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
Qualifications:
- 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, communication, and problem-solving abilities
- Ability to work effectively in a fast-paced environment and handle multiple tasks simultaneously
- Strong attention to detail and accuracy
- JD from an accredited university and excellent academic credentials
- Must be barred in the District of Columbia, or eligible for admission through reciprocity or UBE score transfer
All candidates must be authorized to work in the U.S.
