Head of Regulatory CMC

OverviewJoin to apply for the Head of Regulatory CMC role at Loyal.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. We are pursuing FDA approval for the first lifespan extension drug for any species and have three products in our pipeline. The team includes scientists, veterinarians, engineers, operators, and creatives, and this role will play a key part in supporting our growth itial submissions will be through the FDA Center for Veterinary Medicine. This role leads Loyal's regulatory CMC function, with primary oversight of all CMC-related documents and technical sections for submissions to the FDA and other regulatory authorities. ResponsibilitiesLead Loyal's CMC regulatory strategy and drive a complete CMC dossier for our three drug products, starting with LOY-002.Collaborate with the CMC team to ensure phase-appropriate data support successful regulatory submissions and evaluate formulation decision impacts.Prepare technical sections and other regulatory documents for submission; review protocols and reports to ensure regulatory compliance.Contribute to regulatory plans, strategies, and risk mitigation across the portfolio.Provide regulatory advice to cross-functional teams; draft submission responses to regulatory queries; coordinate with CMC and Quality for scale-up and post-approval changes. Requirements / QualificationsBachelor's degree in a scientific discipline; advanced degree and RAC are pluses but not required.10+ years in the pharmaceutical industry, with 5+ years in animal health and 5+ years in small, growing biotech companies.Well-versed in animal health CMC regulatory requirements and pharmaceutical methods for active ingredients, drug products, and delivery devices.Extensive experience writing regulatory documents including Drug Master Files and/or CMC sections for NADA submissions.Demonstrated success interacting with FDA CVM regarding CMC fortable challenging regulatory precedent while maintaining scientific excellence, integrity, and ethical conduct. CompensationSalary Range: $180,000 - $250,000 BenefitsFull-coverage health insurance (medical, dental, and vision) for you and your dependents$1,000 home office equipment stipend$1,200/year learning budget for books, courses, etc.$250/month wellness budget for gym, cleaners, spa, food, etc.All 3-day weekends are turned into 4-day weekendsUnlimited vacation and paid holidaysPaw-ternity leave — adopt a dog and get a day off with your new family memberCompetitive salaryCompany equity options grant for new hires Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other characteristics protected by law. Our valuesLean into moonshots: We strive for big impact and are not afraid to take risks.Opportunity is at the intersection: We combine disciplines and perspectives to avoid silos.Expertise without ego: We tackle hard problems with collaboration and humility.Learning by doing: We favor MVPs and adaptive outcomes.Lead with context: We empower teams with the background to make decisions.Empathy and respect for all life: Our work respects pets and pet parents. #J-18808-Ljbffr

Created: 2025-09-21