Director, Regulatory Program Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborates with Regulatory Affairs leadership and senior stakeholders to convert regulatory strategies and portfolio priorities into cohesive execution plans.

• Directs the planning and execution of intricate, high-profile regulatory programs across various functions, regions, indications, and products.

• Facilitates effective, action-driven team meetings to streamline operations, decisions, and communications.

• Integrates cross-functional workflows across Research, Development, Regulatory Affairs, Manufacturing, and Medical Writing.

• Establishes and supervises key milestones, critical paths, decision points, objectives, and inflection points throughout regulatory programs.

• Conducts scenario planning and develops decision frameworks to aid timely executive decision-making.

• Collaborates with subject-matter experts to create timelines for essential Regulatory Affairs deliverables supporting MAA/BLA, health authority interactions, and regulatory filings.

• Identifies, manages, and communicates program risks, opportunities, mitigation strategies, and necessary interventions.

• Provides senior leadership with prompt, precise, and actionable insights into program status, risks, decisions, and priorities.

• Delivers insights, recommendations, and program updates to C-suite and senior leadership audiences.

• Ensures consistent implementation of program management standards, dashboards, governance models, and integrated regulatory filing timelines.

• Promotes continuous enhancement of regulatory program management processes, tools, and operating models.

• Drives strategic initiatives to advance the Program Management function as the company expands.

• Mentors and cultivates Program Managers while enhancing organizational capability.

• Reports to the VP or Senior Director of Program Management and may have responsibilities for people leadership.

⛳️ Requirements

• Bachelor's degree with a minimum of 12 years of relevant regulatory project management or scientific experience in the pharmaceutical industry; OR a Master’s or MBA with at least 10 years of relevant experience; OR a PhD in a scientific field, PharmD, or DVM with over 6 years of relevant experience.

• Prior experience in solid tumor oncology is mandatory.

• Extensive experience leading complex, global, cross-functional regulatory programs.

• Proven track record with significant regulatory submissions and interactions with health authorities.

• Experience interacting effectively with senior and executive-level stakeholders and leading through influence in highly matrixed organizations.

• Strong comprehension of pharmaceutical development and the regulatory submission lifecycle.

• Outstanding project management, communication, facilitation, and organizational skills.

• High proficiency in program management and planning tools, including MS Office, Project, and Smartsheet.

• Willingness to travel for important meetings.

🏝️ Benefits

• Bonus, stock options, benefits, and/or other applicable variable compensation may be included in the total compensation package.

• Equal Opportunity Employer.