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Director/Sr. Director, Regulatory Affairs (Strategy, Hematology) - Remote

Posted 29 days agoViewed

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💎 Seniority level: Director, 12 years

📍 Location: United States

🔍 Industry: Biopharmaceutical

🏢 Company: Nurix

🗣️ Languages: English

⏳ Experience: 12 years

🪄 Skills: Project ManagementRisk Management

Requirements:
  • Bachelor's degree in life-sciences or related discipline; advanced degree preferred
  • Minimum of 12 years in Regulatory affairs strategy
  • Strong knowledge of FDA, EMA and ICH guidelines
  • Experience with planning clinical trial and marketing applications
  • Proven track record in major filings
Responsibilities:
  • Develop a comprehensive regulatory strategy
  • Lead and manage global submissions
  • Communicate with global Health Authorities
  • Guide cross-functional teams on risk mitigation
  • Ensure adherence to current regulations
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