FDA Healthcare Associate Attorney

A law firm in Washington, DC is seeking an FDA Healthcare Associate Attorney to provide expert legal advice and support on FDA regulatory matters related to drug and medical device compliance. The ideal candidate will have a strong background in FDA regulations, particularly current good manufacturing practices (CGMP), and will be experienced in counseling biopharma companies. A scientific background or experience with the Food and Drug Administration is highly desirable.

Duties:

• Provide legal advice and support on FDA regulatory matters, including compliance with drug and medical device regulations.
• Conduct comprehensive 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 effective regulatory strategies and ensure adherence to FDA requirements.
• Represent clients during FDA inspections, investigations, and enforcement actions.
• Stay informed on developments in FDA regulations, industry trends, and changes in regulatory requirements.
• Advise on regulatory compliance matters and provide strategic guidance on navigating complex regulatory environments.

Requirements:

• Juris Doctor (J.D.) degree from an accredited law school.
• Admission to the Bar in the District of Columbia, or eligibility for admission through reciprocity or UBE score transfer.
• 4-5 years of experience in FDA regulatory matters, particularly in drug and medical device compliance and CGMP.
• Strong understanding of FDA regulations and compliance issues.
• Prior industry experience in pharmaceutical manufacturing or a scientific background in analytical chemistry, chemical engineering, or microbiology is strongly preferred.
• Experience working at the Food and Drug Administration is a plus.
• Exceptional analytical and problem-solving skills.
• Excellent written and verbal communication abilities.
• Strong attention to detail and accuracy in legal documentation and regulatory compliance.

Education:

• Juris Doctor (J.D.) degree from an accredited law school.

Certifications:

• Bar admission in the District of Columbia, or eligibility for admission through reciprocity or UBE score transfer.

Skills:

• In-depth knowledge of FDA regulations and current good manufacturing practices (CGMP).
• Proven experience in regulatory compliance, particularly in the biopharma industry.
• Ability to conduct thorough legal research and analysis.
• Proficient in drafting and reviewing legal documents, including regulatory submissions and compliance policies.
• Strong communication skills, both written and verbal.
• Capable of working effectively in a fast-paced environment while managing multiple tasks.
• High attention to detail and accuracy.

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