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Salary: USD 110,000 - 160,000 / annual
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs, pioneering a new category of preventative prescription medications targeting the underlying drivers of aging. The company is well-funded and pursuing FDA approval for the first lifespan extension medicine for any species.
You will join the Regulatory Affairs team as Senior Associate Specialist, Regulatory Operations, reporting to the Head of Regulatory, CMC. This role focuses on day-to-day regulatory operations supporting Loyal's longevity pipeline programs.
Key responsibilities include:
- Preparing, reviewing, and assembling clinical and CMC regulatory submissions and reports
- Creating and packaging submissions using the CVM eSubmitter tool, converting author-drafted Word sections into submission-ready formats
- Assembling, formatting, and publishing submissions to FDA CVM and international agencies (INAD/JINAD correspondence, technical sections, amendments, annual reports, meeting requests)
- Managing FDA Electronic Submissions Gateway transmissions, including account administration, receipt reconciliation, and troubleshooting
- Maintaining submission archives and correspondence logs for quick retrieval during review cycles and inspections
- Owning regulatory document templates and submission style guides
- Creating and maintaining submission trackers and regulatory activity documentation
- Collaborating with internal teams (Research, Clinical Development, CMC) on product labeling and documentation
- Staying current on FDA CVM regulatory changes and international authority updates
You bring 3-5 years of regulatory operations experience in human or animal health (animal health preferred), with hands-on expertise in drafting, packaging, and submitting regulatory materials via FDA ESG. You're comfortable with various submission types (H-submissions, Z-submissions, IND/INAD, NDA/NADA, biologics, meeting requests, supplements) and can operate autonomously once strategy is outlined. A bachelor's degree in biology, veterinary medicine, regulatory affairs, or related field is required; relevant experience can substitute. RAPS certification is a bonus. You're collaborative, detail-oriented, and excited about working at the forefront of regulatory category creation.
