Vice President, Regulatory Affairs

About Loyal 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 . You'll help us continue on our path of earning regulatory approval for the first lifespan extension medicine for any species and change what's possible for the dogs we love. About the role Loyal is seeking a Vice President, Regulatory Affairs to lead all aspects of the company's regulatory function, spanning strategy and operations across CMC and clinical regulatory activities. This leader will own the full regulatory program across Loyal's pipeline, from early development through approval and into post approval lifecycle management. A strong CMC regulatory background is essential. The ideal candidate brings deep expertise in small molecule drug development, ideally from human health, with a proven track record leading integrated regulatory teams, executing successful agency interactions, and bringing products to approval. Demonstrated experience in post approval regulatory activities is required. This role requires both strategic vision and operational execution.

The successful candidate will build and lead a regulatory organization capable of supporting Loyal across all stages of development and into a commercial company, and will serve as the primary regulatory authority and the company's primary interface with regulatory agencies globally. The role reports to senior executive leadership and partners closely with leadership across TechOps, Quality, Clinical, Operations, and Commercial. Your daily work will include - Own and drive Loyal's overall regulatory strategy across all active programs, including integrated CMC and clinical regulatory plans aligned with development milestones and commercial objectives, from early development through approval and post approval lifecycle management. - Provide regulatory input into portfolio planning, program prioritization, and business development activities, ensuring regulatory feasibility and risk are embedded in key decisions. - Develop and maintain global regulatory intelligence capabilities, monitoring evolving agency expectations, guidance documents, and industry precedents relevant to Loyal's programs and translating these into actionable strategy. - Provide regular regulatory updates and risk assessments to executive leadership and the board on submission progress, agency interactions, and regulatory risk. - Lead all CMC regulatory activities including filing strategy, CMC section authorship and review, post approval CMC change management, and regulatory oversight of manufacturing and CDMO partners. - Ensure CMC regulatory strategy reflects current agency expectations for small molecule OSD products and is integrated with CMC development plans and manufacturing timelines. - Partner with CMC and Quality leadership on CDMO regulatory readiness, including preparation for pre approval inspections and CMC related agency interactions. - Lead clinical regulatory activities including IND strategy and management, protocol regulatory review, study report oversight, and integration of clinical data into regulatory submissions. - Oversee regulatory strategy for pivotal studies and ensure alignment between study design, endpoints, and agency expectations to support a strong approval package. - Own the approval submission strategy and execution, coordinating across CMC, Clinical, and Quality to ensure submission ready packages that reflect current agency expectations and eCTD standards.