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Salary: USD 280,000 - 340,000 / annual
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. The company is pioneering a new category of veterinary prescription drugs that target the underlying drivers of aging, with significant progress toward first regulatory approvals.
You will lead all aspects of Loyal's regulatory function, spanning strategy and operations across CMC (Chemistry, Manufacturing, and Controls) and clinical regulatory activities. You own the full regulatory program across the pipeline, from early development through approval and into post-approval lifecycle management.
Key responsibilities include:
- Develop and execute Loyal's overall regulatory strategy across all active programs, integrating CMC and clinical regulatory plans aligned with development milestones and commercial objectives
- Provide regulatory input into portfolio planning, program prioritization, and business development activities
- Develop and maintain global regulatory intelligence capabilities, monitoring evolving agency expectations and translating them into actionable strategy
- Provide regular regulatory updates and risk assessments to executive leadership and the board
- Lead all CMC regulatory activities including filing strategy, CMC section authorship, post-approval change management, and regulatory oversight of manufacturing and CDMO partners
- Lead clinical regulatory activities including IND strategy, protocol review, study report oversight, and integration of clinical data into regulatory submissions
- Own approval submission strategy and execution, coordinating across CMC, Clinical, and Quality teams
- Serve as the company's primary liaison with regulatory agencies globally, leading pre-submission meetings, formal submissions, and ongoing communications
- Manage post-approval regulatory obligations including periodic reports, labeling updates, and post-approval study commitments
- Own labeling strategy and content development across the product lifecycle
- Establish regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards
- Build and lead a high-performing regulatory organization with clear functional ownership across CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations
- Establish and scale regulatory governance frameworks and procedural documents
- Serve as the company's independent regulatory authority, escalating regulatory risks and compliance concerns
You will report to senior executive leadership and partner closely with TechOps, Quality, Clinical, Operations, and Commercial leadership.
REQUIREMENTS:
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related scientific discipline, or equivalent bio-technical experience and expertise (required)
- 18+ years of progressive regulatory affairs experience in pharmaceutical or biotech environments
- 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 regulatory teams spanning both CMC and clinical regulatory functions
- 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 (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 ability to serve as the company's primary regulatory authority and represent Loyal credibly with regulatory agencies and senior external stakeholders
PREFERRED:
- Primary experience in human health pharmaceutical or biotech environments (strongly preferred); animal health experience is a plus
- Experience with FDA CVM regulations and veterinary drug approval pathway (NADA/ANADA), or demonstrated ability to develop expertise in novel regulatory frameworks quickly
- Experience filing with and interacting with EMA and major Asian regulatory agencies (PMDA, NMPA, or equivalents)
- Experience supporting first commercial launches and establishing post-approval regulatory infrastructure in companies 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 disciplined, risk-based approach to regulatory strategy and decision-making
