[Hiring] Vice President, Regulatory Affairs @Loyal

Role Description

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.

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.
• Provide regulatory input into portfolio planning, program prioritization, and business development activities.
• Develop and maintain global regulatory intelligence capabilities.
• Provide regular regulatory updates and risk assessments to executive leadership and the board.
• Lead all CMC regulatory activities including filing strategy, CMC section authorship and review, 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.
• Lead clinical regulatory activities including IND strategy and management, protocol regulatory review, and study report oversight.
• Oversee regulatory strategy for pivotal studies.
• Own the approval submission strategy and execution.
• Serve as the company's primary liaison with regulatory agencies globally.
• Manage post-approval regulatory obligations.
• Own labeling strategy and content development across the product lifecycle.
• Establish and own Loyal's regulatory information management infrastructure.
• Build and lead a high performing regulatory organization.
• Establish and scale regulatory governance frameworks and regulatory procedural documents.
• Serve as the company's independent regulatory authority.
• Foster a culture of regulatory excellence and proactive risk management across the organization.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a 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.
• Demonstrated track record of leading regulatory teams spanning both CMC and clinical regulatory functions.
• Proven history of successful agency interactions.
• Demonstrated experience bringing at least one product to regulatory approval.
• 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 with the ability to serve as the company's primary regulatory authority.

Requirements

• 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).
• Experience filing with and interacting with the EMA and major Asian regulatory agencies.
• 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 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 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 — adopt a dog and get a day off with your new family member.
• Competitive salary.
• Company equity options grant for new hires.