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Manager/Senior Manager, Regulatory

Posted 30 days agoViewed

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💎 Seniority level: Manager, 5+ years

📍 Location: United States

🔍 Industry: Biotechnology

🏢 Company: Invivyd👥 101-250💰 $336,000,000 Series C almost 4 years ago🫂 Last layoff 10 months agoPharmaceuticalBiotechnologyTherapeutics

🗣️ Languages: English

⏳ Experience: 5+ years

🪄 Skills: Project ManagementProblem SolvingAttention to detail

Requirements:
  • BA/BS degree in biological/physical sciences required
  • 5+ years relevant Regulatory Affairs experience
  • Strong understanding of drug development process and regulatory requirements
  • Experience with document management and RIM systems
Responsibilities:
  • Execute regulatory strategies and compile regulatory submissions
  • Lead Agency interaction documents compilation
  • Organize and maintain regulatory files within RIM system
  • Guide associates or contractors with regional requests
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