Loyal

Vice President

• Build out Loyal's consumer and veterinary marketing capabilities for the anticipated launch of LOY-002.
• Own the marketing and communications plan end to end, including category strategy, audiences, channels, messaging, and brand presence.
• Build a new medicine category for veterinary professionals and consumers.
• Develop early messaging and positioning for aging care.
• Define target audiences and the best ways to reach them.
• Build concrete launch plans and define pre-approval success metrics.
• Build and prepare the marketing team as launch approaches.
• Establish capabilities to educate veterinary professionals, drive consumer demand, and grow awareness of Loyal.
• Own company communications and set strategy for communicating the R&D pipeline, publications, partnerships, and Loyal's role in longevity and senior dog care.
• Report to the VP of Commercial and lead the existing marketing team of two.

Vice President, Marketing

• Own and drive Loyal's overall regulatory strategy across all active programs, including integrated CMC and clinical regulatory plans from early development through approval and post approval lifecycle management.
• Provide regulatory input into portfolio planning, program prioritization, and business development activities.
• Develop and maintain global regulatory intelligence capabilities and translate agency expectations, guidance, and industry precedents into actionable strategy.
• Provide regulatory updates and risk assessments to executive leadership and the board.
• Lead CMC regulatory activities, including filing strategy, CMC section authorship and review, post approval CMC change management, and oversight of manufacturing and CDMO partners.
• Partner with CMC and Quality leadership on CDMO regulatory readiness, pre approval inspections, and CMC-related agency interactions.
• Lead clinical regulatory activities, including IND strategy and management, protocol regulatory review, study report oversight, and clinical data integration into submissions.
• Oversee regulatory strategy for pivotal studies and align study design, endpoints, and agency expectations.
• Own approval submission strategy and execution across CMC, Clinical, and Quality, ensuring submission-ready packages reflect agency expectations and eCTD standards.
• Serve as Loyal's primary liaison with global regulatory agencies for pre-submission meetings, formal submissions, and ongoing communications.
• Manage post approval obligations, including periodic reports, labeling updates, post approval study commitments, and CMC variation filings.
• Own labeling strategy and content development throughout the product lifecycle.
• Establish and own regulatory information management infrastructure, eCTD publishing capability, and submission archiving standards.
• Build and lead a high-performing regulatory organization across CMC regulatory, clinical regulatory, submissions management, labeling, and regulatory operations.
• Establish and scale regulatory governance frameworks and procedural documents for submissions, agency meetings, labeling reviews, and regulatory decisions.
• Serve as the independent regulatory authority, escalating risks and compliance concerns to executives.
• Foster regulatory excellence and proactive risk management across the organization.

Vice President, Marketing

Vice President, Regulatory Affairs