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)Medical Machine Learning Information Technology Health 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.