Director, Regulatory Program Management

Overview

The Director, Regulatory Program Management (RPM), provides strategic and operational leadership for high-priority, complex regulatory filings and submissions across the product portfolio. This role drives alignment across Research, Development, Regulatory Affairs, Manufacturing, and execution teams to ensure regulatory objectives are delivered with clarity, rigor, and accountability.

The Director partners closely with Regulatory Affairs, Medical Writing, Program Leadership, and cross-functional development teams to translate portfolio and regulatory strategies into executable plans. The role serves as a key contact for executive leadership and supports disciplined governance and strengthens the Program Management function as the organization scales.

In addition, this leader contributes to developing the operating model for regulatory project management, advances portfolio-level visibility, and builds organizational capability to support complex submissions, health-authority interactions, and other critical regulatory initiatives. This position reports to the VP or Sr. Dir, Program Management and may have people leadership responsibilities.

Role and Responsibilities

• Partners with Regulatory Affairs leadership and senior stakeholders to translate regulatory strategy and portfolio priorities into integrated execution plans.
• Leads planning and execution of complex, high-visibility regulatory programs across functions, regions, indications, and products.
• Chairs efficient, action-oriented team meetings to coordinate operations, decisions, and communications.
• Integrates cross-functional workstreams across Research, Development, Regulatory Affairs, Manufacturing, Medical Writing as appropriate.
• Defines and oversees major milestones, critical paths, decision points, objectives, and inflection points across regulatory programs.
• Leads scenario planning and decision frameworks to support timely executive decision-making.
• Works with SMEs to develop timelines for key RA deliverables to support MAA/BLA, HA interactions, and regulatory filings and ensures deliverables are on track.
• Identifies, manages, and communicates program risks, opportunities, mitigation strategies, and required interventions.
• Provides senior leadership with timely, accurate, and actionable visibility into program status, risks, decisions, and priorities. Present clear insights, recommendations, and program updates to C-suite and senior leadership audiences.
• Ensures consistent application of program management standards, dashboards, governance models, and integrated regulatory filing timelines aligned with enterprise goals.
• Supports continuous improvement of regulatory program management processes, tools, and operating models.
• Leads strategic initiatives to mature the Program Management function as the company grows.
• Mentors and develops Program Managers and strengthen organizational capability.

Experience, Education and Specialized Knowledge

• Bachelor’s degree and minimum 12 years of relevant regulatory project management/scientific experience within the pharmaceutical industry; OR a MS or MBA and minimal 10 years of relevant experience; OR a PhD in a scientific field or a PharmD, or DVM with 6+ years of relevant experience
• Prior solid tumor oncology experience required
• Significant experience leading complex, global, cross-functional regulatory programs.
• Demonstrated experience with major regulatory submissions and health-authority interactions.
• Experience operating effectively with senior and executive-level stakeholders and leading through influence in highly matrixed organizations.
• Strong understanding of pharmaceutical development and the regulatory submission lifecycle.
• Exceptional project-management, communication, facilitation, and organizational capabilities.
• Strong proficiency in program management and planning tools (e.g., MS Office, Project, Smartsheet)
• Willing to travel for key meetings.