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Venesco, LLC
Senior Regulatory Affairs ScientistVenesco, LLC • Falls Church, VA, United States
Senior Regulatory Affairs Scientist

Senior Regulatory Affairs Scientist

Venesco, LLC • Falls Church, VA, United States
Hace 23 horas
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Senior Regulatory Affairs Scientist

Join a dynamic regulatory team as a Senior Regulatory Affairs Scientist, where you will lead submission strategies and regulatory interactions for innovative medical products.

Key responsibilities include:

  • Develop and execute regulatory strategies and submission plans
  • Prepare and submit INDs, NDAs, BLAs, and IDEs
  • Serve as primary liaison with FDA and regulatory agencies
  • Provide regulatory guidance to cross-functional teams
  • Monitor regulatory trends and ensure compliance with evolving requirements
  • Review and approve regulatory documentation

Qualifications:

  • Advanced degree in regulatory science, biology, or related field
  • 8+ years of regulatory affairs experience
  • Strong knowledge of FDA regulations and ICH guidelines

Preferred:

  • RAC certification
  • Experience with electronic submissions (eCTD)
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Senior Regulatory Affairs Scientist • Falls Church, VA, United States

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