Senior Associate Specialist, Regulatory Operations
Benefits
Unlimited PTO
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About the Role:
- You will work directly on day-to-day regulatory operations supporting our programs.
- You will compile, format, and electronically submit materials to the FDA CVM.
- You will own and update trackers regarding our submissions.
Your Daily Work:
- Assist in preparing and reviewing both Clinical and CMC regulatory submissions and reports.
- Create and package submissions using the CVM eSubmitter tool.
- Maintain the submission archive and correspondence log.
About You:
- You have 3-5 years of regulatory ops experience in human or animal health.
- You are proficient with FDA ESG and various submission types.
- You are collaborative and can operate with autonomy.
Benefits:
- Full-coverage health insurance including medical, dental, and vision.
- Unlimited vacation and paid holidays.
- Education budget, wellness budget, and home office stipend.
Loyal
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. We are a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives.