Senior Director, Regulatory Science Communication

Kardigan • Princeton, NJ

5h • $248,000 - $310,000 • Onsite

About The Position

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable. The company aims to develop targeted treatments to address cardiovascular diseases. Led by experienced individuals who previously led MyoKardia to develop mavacamten, Kardigan possesses a strong research platform, a promising pipeline, and a driven team focused on patient well-being. The company's values emphasize patient-centricity, authenticity, continuous learning, teamwork, and enabling the impossible through innovation and risk-taking.

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 across development stages
• Strong expertise in development of regulatory documentation, including briefing books, eCTD content, clinical summaries, protocols, CSRs, and health authority responses
• Deep understanding of global regulatory frameworks and guidelines, including FDA, EMA, and ICH requirements
• Proven ability to influence senior cross-functional stakeholders to drive alignment

Nice To Haves

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

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, as needed, direct authoring support for critical regulatory documents, ensuring they are fit for purpose, scientifically sound, and compliant with global regulatory standards
• Oversee development of key regulatory content, including briefing documents, response packages, eCTD Module 2 summaries and overviews, protocols and protocol amendments, clinical study reports (CSRs), and responses to health authority questions
• Partner with regulatory leaders and cross-functional teams to ensure that submission documents reflect a clear, persuasive, and evidence-based scientific narrative that accurately interprets complex clinical, statistical, and safety data for regulatory audiences
• Establish and continuously improve standards, templates, style guides, and content frameworks that support efficient, high-quality regulatory document development.
• Champion the thoughtful use of digital and AI-enabled tools to improve document planning, content development, and review workflows while maintaining scientific integrity and compliance
• Ensure that regulatory communications meet GxP, inspection-readiness, and documentation standards appropriate for global development and submission activities
• Provide leadership, coaching, and direction to internal writers, external vendors, and contract medical or regulatory writers as applicable.

Benefits

• Exact Compensation may vary based on skills, experience and location.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree