Senior Director, Regulatory Science Communication

Position Title: Senior Director, Regulatory Science Communication

Department: Regulatory

Reports To: SVP, Head of Regulatory

Location: South San Francisco, CA or Princeton, NJ – On site 4 days a week (Mon to Thurs)

Job Overview

The Senior Director, Regulatory Science Communication is a strategic leadership role responsible for the development, alignment, and execution of high-impact regulatory communication strategies. This individual leads the development of clear, scientifically rigorous, and compliant regulatory content that supports health authority interactions, product approvals, and lifecycle management globally. This role serves as a key partner to Regulatory Affairs, Clinical Development, Biostatistics, Pharmacovigilance, and other cross-functional stakeholders. The Senior Director is expected to provide both strategic direction and hands-on leadership across document planning, content development, review and approval.

Essential Duties and Responsibilities

Key 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.

Qualifications and Preferred Skills

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