Regulatory Affairs Specialist - Remote

Overview

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.

In Short

• Seeking a Regulatory Affairs Specialist to assist with regulatory submissions and operations.
• Support regulatory approval of programs and compliance with regulations around clinical trials.
• Ideal for someone in the early stages of their career in Regulatory Affairs.
• Work independently while being open to guidance.
• Report to the Senior Scientist, Regulatory Affairs.
• Prepare and submit regulatory filings including SAE reporting.
• Support regulatory intelligence activities and research FDA regulations.
• Assist the regulatory team in responding to inquiries from regulatory agencies.
• Advanced degree in life sciences preferred.
• Experience in the biotech industry is beneficial.

Requirements

• 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 its application to company programs.
• Broad understanding of drug development and approval processes.
• Some experience in the biotech industry.
• RAPS certification is a bonus but not required.

Benefits

• Equal opportunity employer.
• Supportive work environment.
• Opportunity to work on innovative projects.
• Collaborative team culture.
• Focus on personal and professional growth.