Regulatory Operations Specialist

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