Director, Regulatory Affairs – Clinical

Role Overview

• Authoring and reviewing regulatory submissions, including INAD filings, study reports, clinical trial evaluability meetings, and agency correspondence
• Leading preparation for FDA CVM meetings, including  briefing documents, meeting requests, posing questions, and follow-up MOCs
• Partnering with clinical teams to provide real-time regulatory guidance on active studies, including SAE submissions, BIMO preparedness, and NCIE reports
• Reviewing and preparing study protocols, ICFs, and amendments to ensure the highest quality submissions for pivotal protocol concurrence
• Monitoring and interpreting CVM guidance, policy updates, and precedent to inform Loyal's regulatory strategy across our pipeline
• Anticipating and resolving regulatory risks across functions (including R&D, CMC, and commercial) throughout the portfolio before they become problems
• Managing and mentoring 1–2 direct reports, providing feedback, priorities, and development support
• Collaborating cross-functionally with R&D, clinical development, clinical operations, data management, and legal teams on submissions and strategy
• Oversee the maintenance and organization of all regulatory records and interactions related to Loyal’s drug programs
• Serving as the internal subject matter expert for any question touching FDA CVM clinical requirements — from study design to labeling to adverse event reporting
• Reviewing and advising on external facing pre-approval communications and activities to ensure compliance with FDA CVM regulations
• Reviewing and providing guidance on labeling materials for submission to ensure compliance with FDA CVM regulations

Requirements

• Bachelor’s degree in relevant field (biology, vet med, regulatory affairs or related); relevant experience > specific degree
• 10+ years of regulatory affairs experience in animal health with direct experience with owning FDA CVM relationships
• Hands on ownership experience with INADs, regulatory submissions, and FDA CVM in-person meetings
• Background across multiple drug types ideal (small molecules, biologics, injectables, etc.)
• You are data-driven and an analytical thinker; your regulatory experience is grounded in evidence and you communicate with excellence
• Strong and experienced writer that takes pride in clarity, accuracy and persuasive story telling about biological pathways or drug mechanisms and clinical impacts
• Extensive knowledge of FDA CVM regulatory pathways, policies, and limitations and where there are areas to innovate within those bounds
• Excellent judgement where FDA CVM is concerned and comfortable being the single source of strategic conviction using that judgement
• Collaborative with cross-functional teams and not afraid to be in the weeds while also being the subject matter expert
• Ability to operate as a high level individual contributor while also serving as a mentor to junior team members in order to upskill the department.
• Energized by a fast-paced startup environment

Benefits

• Full-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 weekends 🎉
• Unlimited vacation and paid holidays
• Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
• Competitive salary
• Company equity options grant for new hires