Vice President, CMC Regulatory Affairs

The role

The Vice President, CMC Regulatory Affairs will lead the strategy and operations for all CMC regulatory activities across the pipeline. This leader will own the CMC regulatory program from early development through approval and post-approval lifecycle management.

What you will do

• Own and drive the overall CMC regulatory strategy across all active programs.
• Provide CMC regulatory input into portfolio planning and business development.
• 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 and CMC section authorship.
• Ensure CMC regulatory strategy reflects current agency expectations for small molecule OSD products.
• Partner with CMC and Quality leadership on CDMO regulatory readiness.
• Own the CMC technical section strategy and execution.
• Serve as the primary liaison with regulatory agencies globally on CMC matters.
• Manage post approval regulatory obligations including periodic reports and labeling updates.

Required qualifications

• 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
• 10+ years in senior regulatory leadership roles within sponsor organizations
• Strong CMC regulatory background with deep expertise in small molecule drug development
• Demonstrated track record of leading CMC regulatory teams
• Proven history of successful agency interactions
• Demonstrated experience bringing at least one product to regulatory approval, including NDA, MAA, or equivalent submission leadership
• Required experience with post approval regulatory activities
• 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

Nice to have

• Primary experience in human health pharmaceutical or biotech environments
• Animal health experience
• Experience with FDA CVM regulations and the veterinary drug approval pathway (NADA/ANADA)
• Experience filing with and interacting with the EMA and major Asian regulatory agencies (PMDA, NMPA, or equivalents)
• Experience supporting first commercial launches and establishing post approval regulatory infrastructure
• Familiarity with eCTD submission standards and regulatory operations best practices
• Experience leading organizations through significant growth, transformation, or regulatory milestone events
• Strong systems thinking mindset

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 for books, courses, etc.
• $250/month wellness budget for gym, cleaners, spa, food, etc.
• All 3-day weekends are turned into 4-day weekends
• Unlimited vacation and paid holidays
• Paw-ternity leave
• Competitive salary
• Company equity options grant for new hires

About the company

Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. The company is a well-funded startup pioneering a new category of veterinary prescription drugs.