Director, Regulatory Program Management

Summit Therapeutics, Inc.

. Partners with Regulatory Affairs leadership and senior stakeholders to translate regulatory strategy and portfolio priorities into integrated execution plans .

Posted 9/21/2026full-timeRemote • United StatesLead💰 $190,000 - $237,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in leading complex regulatory programs within the pharmaceutical industry, with a strong focus on project management, stakeholder engagement, and regulatory submission processes. Capable of mentoring teams and driving strategic initiatives to enhance program management functions.

Highest-signal resume keywords

Regulatory Project ManagementComplex Global Regulatory ProgramsHealth-Authority InteractionsPharmaceutical DevelopmentProgram Management Tools

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsProject ManagementProgram PlanningRisk ManagementScenario Planning

Soft Skills

CommunicationFacilitationOrganizational SkillsLeadershipInfluence

Tools & Technologies

MS OfficeMS ProjectSmartsheet

Industry Keywords

Pharmaceutical IndustrySolid Tumor OncologyRegulatory AffairsC-Suite PresentationsIntegrated Regulatory Filing Timelines

About the role

Key responsibilities & impact

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, and Medical Writing
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 subject-matter experts to develop timelines for key Regulatory Affairs deliverables supporting MAA/BLA, health-authority interactions, and regulatory filings
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
Presents 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
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 strengthens organizational capability
Reports to the VP or Senior Director of Program Management and may have people leadership responsibilities

Requirements

What you’ll need

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, including MS Office, Project, and Smartsheet
Willing to travel for key meetings

Benefits

Comp & perks

Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package
Equal Opportunity Employer