Latigo Creative

Compliance

• Report to the Vice President of Regulatory
• Lead execution and implementation of regulatory strategies supporting product development
• Support regulatory interactions with FDA, EMA, MHRA, and other global health authorities
• Provide regulatory input into clinical development plans, study designs, and labeling strategies
• Anticipate and mitigate regulatory risks and develop contingency plans
• Oversee preparation, review, and submission of INDs, CTAs, NDAs, briefing documents, and other regulatory documents
• Ensure regulatory submissions are timely, complete, and accurate
• Maintain knowledge of applicable regulatory requirements and ensure organizational compliance
• Lead or support regulatory meeting requests and briefing documents for FDA Type B/C meetings and equivalent ex-US interactions
• Partner with Clinical Development, CMC, Nonclinical, Quality, and leadership teams
• Provide regulatory guidance on study protocols, statistical analysis plans, and clinical trial conduct
• Apply a quality mindset to CMC submissions and inspections

Director, Regulatory Affairs