Senior Associate Specialist, Regulatory Operations

Senior Associate Specialist, Regulatory Operations at Loyal, United States (nationwide) (nationwide) - Full Time, No Remote

About the Role

We are seeking an experienced Sr. Associate Specialist, Regulatory Operations to join our team and support our day-to-day regulatory operations that drive our programs forward. This role requires a deep understanding of operational aspects such as compiling and formatting regulatory submissions, electronically submitting materials to the FDA/CVM, and managing trackers for ongoing projects.

Responsibilities

• Compile and format regulatory submissions in compliance with FDA/CVM guidelines
• Electronically submit materials to the FDA/CVM on a regular basis
• Create, own, and update trackers for our ongoing submission processes
• Contribute to the regulatory path towards FDA CVM approval of novel longevity therapeutics
• Collaborate with cross-functional teams to ensure efficient and accurate regulatory filings

Qualifications

This role is ideal for someone with at least 3 years of experience in Regulatory Operations. Key qualifications include:

• Familiarity with the operational aspects of regulatory affairs
• Experience in compiling and formatting regulatory submissions
• Ability to manage and update trackers for ongoing projects
• Comfort collaborating with cross-functional teams

About Loyal

Loyal is a clinical-stage veterinary medicine company dedicated to developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives by pioneering new categories of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging. We have made significant progress toward our first regulatory approvals with additional submissions targeted in the near future.

Next Steps

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.