Manager, Global Regulatory Affairs Project Management

Core Responsibilities

• Partner with the Director, Global Regulatory Affairs Project Management to lead regulatory submission activities from initiation through submission, defining scope, priorities, timelines, resource requirements, risks, and key deliverables to ensure successful execution.
• Oversee cross-functional planning and coordination for global regulatory submissions, including INDs, CTAs, NDAs, MAAs, and other major filings, partnering with Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants).
• Maintain and communicate integrated submission plans and schedules, proactively tracking progress, identifying risks and dependencies, and implementing mitigation strategies to support on-time regulatory milestones and agency interactions.
• Partner with Global and Regional Regulatory Science Leads to support the execution of global regulatory strategies for assigned molecules across indications.
• Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level.
• Propose and support implementation of operational solutions, including process improvements, as appropriate.
• Partner with the Director, Global Regulatory Affairs Project Management to build and maintain submission dashboards; communicate status, risks, and mitigation strategies to key stakeholders.
• Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.
• Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.

Required Skills, Experience and Education

• Bachelor’s degree in a life sciences or related discipline with 5+ years of pharma / biotech industry experience, including 3+ years of regulatory project management experience.
• Working knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.
• Working knowledge of global regulatory regulations, guidelines, and submission pathways; familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.
• Strong project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.
• Excellent communication and interpersonal skills, with demonstrated ability to influence, manage group dynamics, and balance functional, team, and leadership objectives.
• High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis; experience with OnePager, Office Timeline, and Veeva RIM is a plus.