Director, Regulatory Affairs – Clinical

Loyal

Director of Regulatory Affairs at Loyal managing FDA CVM regulatory strategy and clinical trials. Leading submissions and agency interactions for longevity drugs development in veterinary medicine.

Posted 4/22/2026full-timeRemote • 🇺🇸 United StatesLead💰 $155,000 - $205,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsINAD filingsclinical trial evaluabilitySAE submissionsBIMO preparednessNCIE reportsstudy protocolsICFsFDA CVM regulationsdata analysis

Soft Skills

leadershipmentoringcollaborationcommunicationanalytical thinkingjudgmentproblem-solvingwritingstorytellingadaptability