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Regulatory Affairs Specialist - Part Time Contract

Posted 26 days agoViewed

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💎 Seniority level: Entry, some experience

📍 Location: US

💸 Salary: 50.0 USD per hour

🔍 Industry: Veterinary Medicine

🏢 Company: Loyal👥 101-250💰 $33,500,000 Series B 8 months agoArtificial Intelligence (AI)MedicalMachine LearningInformation TechnologyHealth Care

🗣️ Languages: English

⏳ Experience: Some experience

🪄 Skills: Attention to detailComplianceResearchWriting

Requirements:
  • Have an advanced degree BS in a life sciences field, (MS, PhD) preferred
  • Good attention to detail, ability to write clear and concise documents
  • Interest in regulatory science and how to apply it to company programs
  • A broad understanding of drug development and approval processes
  • Have some experience in the biotech industry
Responsibilities:
  • Assisting in the preparation and submission of regulatory filings including Serious Adverse Event (SAE) reporting and drug shipment notifications for our ongoing clinical trial.
  • Providing support with regulatory intelligence activities, including the research of new and existing FDA regulations or guidances.
  • Providing support to the regulatory team in responding to inquiries from regulatory agencies.
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