Vice President, Regulatory Affairs (Fully Remote)

Loyal; United States; Remote; USD 150,000 - 230,000; Full time

Benefits offered by this job

Health insurance

Unlimited vacation

Paid holidays

Equity options

Learning budget

Wellness budget

Job summary

Loyal is seeking a senior regulatory leader to own and drive the full regulatory program across its veterinary-focused pipeline from early development to post-approval. You will serve as the primary regulatory interface with global agencies and drive strategy aligned with development milestones and commercial goals.

You will lead CMC and clinical regulatory activities, including IND strategy and submissions, and help build regulatory information management and eCTD publishing capabilities to

Qualifications

• Bachelor level or higher in life sciences or related field (not specified in ad)
• Proven experience in regulatory strategy and cross-functional leadership

Responsibilities

• Own the full regulatory program across Loyal's pipeline from development to post-approval
• Serve as Loyal's primary regulatory authority and interface with agencies globally
• Drive regulatory strategy integrated with development milestones and commercial objectives
• Lead CMC and clinical regulatory activities including IND strategy, submissions, and post-approval obligations
• Establish regulatory information management infrastructure and eCTD publishing capabilities

Skills

Regulatory affairs

Stakeholder management

Strategic thinking

Tools

eCTD publishing

Job description

• Own the full regulatory program across Loyal's pipeline, from early development through approval and post-approval lifecycle management.
• Serve as the company's primary regulatory authority and interface with regulatory agencies globally.

Key responsibilities:

• Drive regulatory strategy integrated with development milestones and commercial objectives.
• Lead CMC and clinical regulatory activities, including IND strategy, approval submissions, and post-approval obligations.
• Establish regulatory information management infrastructure and eCTD publishing capabilities.
• Full-coverage health insurance for you and your dependents.
• Unlimited vacation and paid holidays, plus 4-day weekends.
• Company equity options grant and learning/wellness budgets.

Loyal

Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. It is a well-funded startup led by a first gen female CEO, with a culture focused on innovation, transparency, and empathy for all life.