Director, Regulatory Affairs - Clinical

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives. We’re pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress toward our first regulatory approvals, with additional submissions targeted in the near future. Loyal is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love. About the role We’re seeking an experienced Director Regulatory Affairs, Clinical to serve as Loyal’s subject matter expert on FDA Center for Veterinary Medicine (CVM) regulatory strategy and clinical trial operations. This is a high-impact, hands‑on role for someone who thrives on owning complex regulatory programs end‑to‑end — from INAD strategy through pivotal submission — and who brings deep expertise in FDA CVM clinical development. You will be the primary interface between Loyal and FDA CVM for clinical regulatory matters, owning our regulatory submissions, and helping shape the strategies that bring our longevity drugs to market. You will also manage 1–2 direct reports as the team grows. Your work will directly shape the regulatory path to bring novel longevity therapeutics through FDA CVM approval for the first time in any species, setting regulatory precedent for an entirely new category of medications. This role is for someone who has at least 10+ years of regulatory affairs experience. The ideal candidate should be a strategic thinker that is comfortable owning complex, first‑of‑kind regulatory programs with limited precedent, possess deep working knowledge of FDA CVM clinical development pathways and submission requirements and thrive in an environment operating with a great deal of autonomy in setting direction, making judgment calls, and driving programs and regulatory pathways forward in an agile organization. You will be reporting to our VP of Regulatory Affairs. Your daily work will include 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 Overseeing 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 About you Bachelor’s degree in relevant field (biology, vet med, regulatory affairs or related); relevant experience greater than specific degree 10+ years of regulatory affairs experience in animal health with direct experience 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 storytelling 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 judgment where FDA CVM is concerned and comfortable being the single source of strategic conviction using that judgment 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 Salary Range: $155,000 - $205,000 Full‑coverage health insurance — medical, dental, and vision — for you and your dependents $1,000 home office equipment stipend $250/month wellness budget for gym, cleaners, spa, food, etc. All three‑day weekends are turned into four‑day weekends Unlimited vacation and paid holidays Company 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 against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. #J-18808-Ljbffr