Talent Job Seeker
Healthcare - Attorney
- directions_car Washington D.C.
- work Full-time
About the position
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.
Place of work
Talent Job Seeker
Washington D.C.
app.general.countries.United States
Washington D.C.
app.general.countries.United States
About the company
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Relevant places near
- Washington
- Arlington
- Alexandria
- Silver Spring
- Bethesda
- Aspen Hill
- Wheaton
- McLean
- Potomac
- North Bethesda
Job ID: 9712999
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