Senior Director, Regulatory Science Communication

About the Company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. Led by industry veterans, the company utilizes a cutting-edge discovery and translational research platform to develop targeted treatments for cardiovascular diseases.

Responsibilities

• Lead the strategic development and execution of integrated regulatory science communication plans across the product lifecycle
• Align communication strategies with overall regulatory objectives, clinical development plans, and benefit-risk assessments
• Provide strategic oversight and direct authoring support for critical regulatory documents to ensure they are scientifically sound and compliant
• Oversee development of key regulatory content including briefing documents, response packages, eCTD Module 2 summaries, protocols, and clinical study reports (CSRs)
• Partner with regulatory leaders and cross-functional teams to ensure submission documents reflect a clear, persuasive, and evidence-based scientific narrative
• Establish and improve standards, templates, style guides, and content frameworks
• Champion the use of digital and AI-enabled tools to improve document planning and review workflows
• Ensure regulatory communications meet GxP and inspection-readiness standards
• Provide leadership, coaching, and direction to internal writers and external vendors

Requirements

• 10+ years of experience in regulatory affairs, regulatory writing, medical writing, or scientific communication
• Demonstrated experience supporting global regulatory submissions and health authority interactions
• Strong expertise in development of regulatory documentation (briefing books, eCTD content, protocols, CSRs)
• Deep understanding of global regulatory frameworks including FDA, EMA, and ICH requirements
• Proven ability to influence senior cross-functional stakeholders

Preferred Qualifications

• Advanced degree (PhD, PharmD, MD, or equivalent in life sciences or related discipline)