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Healthcare - Attorney
Healthcare - AttorneyQuantus Management Resources • Washington D.C., District of Columbia, United States
Healthcare - Attorney

Healthcare - Attorney

Quantus Management Resources • Washington D.C., District of Columbia, United States
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IMPORTANT :

Must Have Experience in Healthcare & Life Sciences!

A global law firm is looking for an experienced FDA Regulatory Attorney with a Big Law background 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 law in District of Columbia
  • Minimum of 2 Years of Experience in Healthcare & Lifesciences space 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.
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    Attorney • Washington D.C., District of Columbia, United States

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