Associate Attorney (FDA Regulatory)

A global law firm is looking for an experienced FDA regulatory associate to join their Healthcare & Life Sciences Practice in Washington DC.

RESPONSIBILITIES:

• Ensure products and processes adhere to FDA regulations throughout their lifecycle.
• Provide legal guidance on product development, clinical trials, and market launch strategies.
• Draft and review regulatory submissions, such as Investigational New Drug applications (INDs) and New Drug Applications (NDAs), and other pre-market and post-market reports.
• Interpret and apply FDA laws, regulations, and guidance documents.
• Evaluate potential legal risks associated with FDA regulations and advising on mitigation strategies.
• Represent clients in interactions with the FDA, including responding to agency inquiries and participating in meetings.
• Monitor and analyze changes in FDA regulations, policies, and guidance documents.
• Work with various teams, including scientists, quality assurance professionals, and business leaders, to ensure regulatory compliance.
• Assist in litigation related to FDA enforcement actions.

MUST HAVE:

• Juris Doctor (J.D.) degree - Cum Laude or better
• License to practice in District of Columbia
• Minimum of 2 years of experience advising clients in FDA regulatory matters, including transactional matters involving FDA-regulated entities.
• Experience in product development, clinical trials, launch and marketing, and with the government regulators at every stage of the FDA-regulated product life cycle is preferred.
• Possess outstanding writing skills and a desire to join a dynamic, diverse, and fast-paced practice area.

NICE TO HAVE:

• Big Law background, preferably top 100 law firm.