Regulatory Operations Specialist

Job Summary

Seeking a detail-oriented Senior Associate Specialist in Regulatory Operations, this full-time remote position will manage the preparation and submission of regulatory documents to the FDA and other agencies, ensuring compliance and tracking progress for a pioneering veterinary medicine company.

Key responsibilities

• Assist in preparing and reviewing Clinical and CMC regulatory submissions and reports
• Create and package submissions using the CVM eSubmitter tool, ensuring accuracy and compliance
• Maintain submission archives and trackers, collaborating with cross-functional teams on product documentation

Required qualifications

• Bachelor's degree in a relevant field such as biology, veterinary medicine, or regulatory affairs
• 3-5 years of regulatory operations experience in human or animal health, with a preference for animal health
• Hands-on experience with regulatory submissions to the FDA via the Electronic Submissions Gateway
• Familiarity with various regulatory submission types, including INAD and NDA
• Ability to work autonomously while managing multiple submissions and deadlines