Vice President, CMC Regulatory Affairs

Loyal is seeking a Vice President, CMC Regulatory Affairs to lead the strategy and operations across all CMC regulatory activities. This leader will own the full CMC regulatory program across Loyal's pipeline, from early development through approval and into post approval lifecycle management. The role reports to senior executive leadership and partners closely with leadership across TechOps, Quality, Clinical, Operations, and Commercial. Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs.

Responsibilities

Own and drive overall CMC regulatory strategy across all active programs, from early development through approval and post approval lifecycle management; Provide CMC regulatory input into portfolio planning, program prioritization, and business development activities; Develop and maintain global regulatory intelligence capabilities; Provide regular CMC regulatory updates and risk assessments to executive leadership and the board; 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; Partner with CMC and Quality leadership on CDMO regulatory readiness, including pre-approval inspections; Own the CMC technical section strategy and execution, ensuring submission ready eCTD packages; Serve as primary liaison with regulatory agencies globally on CMC matters; Manage post approval regulatory obligations including periodic reports, labeling updates, post approval study commitments, and CMC variation filings; Establish and own regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards; Build and lead a high performing CMC regulatory organization; Establish and scale regulatory governance frameworks and procedural documents; Serve as the company's independent CMC regulatory authority with accountability to escalate regulatory risks; Foster a culture of regulatory excellence and proactive risk management

Requirements

Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or equivalent bio-technical experience and expertise; 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech environments, with 10+ years in senior regulatory leadership roles within sponsor organizations; Strong CMC regulatory background with deep expertise in small molecule drug development, including OSD formulation, manufacturing process regulatory strategy, CMC section authorship, and post approval change management; Demonstrated track record of leading CMC regulatory teams; Proven history of successful agency interactions, including pre submission meetings, formal correspondence, and advisory interactions across the product development lifecycle; Demonstrated experience bringing at least one product to regulatory approval, including NDA, MAA, or equivalent submission leadership; Required experience with post approval regulatory activities, including CMC change management, labeling updates, periodic safety and annual reports, and post approval study commitments; Experience building and scaling regulatory organizations in startup or high growth environments; Strong working knowledge of ICH guidelines and regulatory requirements across relevant global markets; Executive presence with the ability to serve as the company's primary regulatory authority and represent Loyal credibly with regulatory agencies and senior external stakeholders

Nice to have

Primary experience in human health pharmaceutical or biotech environments, strongly preferred; animal health experience is a plus; Experience with FDA CVM regulations and the veterinary drug approval pathway (NADA/ANADA) or demonstrated ability to develop expertise in a novel regulatory framework quickly; Experience filing with and interacting with the EMA and major Asian regulatory agencies (PMDA, NMPA, or equivalents) is a significant plus; Experience supporting first commercial launches and establishing post approval regulatory infrastructure in a company scaling toward commercialization; Familiarity with eCTD submission standards and regulatory operations best practices for late stage development companies; Experience leading organizations through significant growth, transformation, or regulatory milestone events; Strong systems thinking mindset with a disciplined, risk-based approach to regulatory strategy and decision-making

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; $250/month wellness budget; All 3-day weekends turned into 4-day weekends; Unlimited vacation and paid holidays; Paw-ternity leave; Competitive salary; Company equity options grant for new hires