Senior Manager, Regulatory Affairs Project Management

Role Summary

We are seeking an experienced biotech project manager to optimize planning, execution, and tracking of development-stage global regulatory activities. This role will be a key member of the team supporting regulatory activities and regulatory execution for clinical trials across the portfolio. In collaboration with the Regulatory team, you will drive global submission planning and coordination across multiple regions, ensuring alignment with Regulatory, Global Development, and Technical Operations objectives. The ideal candidate is a proactive, detail-oriented project manager with global regulatory experience who thrives in a fast-paced, collaborative biotech environment.

Reporting to the Director of Program Management, you will also work closely with other project and program managers within the Program Management Office (PMO) implementing robust PM processes and building effective tools and systems. You'll support optimization of Regulatory project plans, schedules, stakeholder communications, and Smartsheet operations. The role involves developing and managing high-visibility regulatory submission plans, monitoring milestones, managing documentation, and contributing to regulatory strategy.

Key Responsibilities

• This role blends regulatory expertise with advanced project management skills, developing complex plans to enable successful Regulatory submission activities and ensuring cross-functional integration across regions
• Track and coordinate timelines and deliverables to support complex regulatory submission activities (IND/CTA/BLA/NDA/MAA) across multiple regions, as well as responses to queries and correspondence with subject matter experts
• Work with the Regulatory team to translate strategic regulatory vision into actionable project plans, ensuring all cross-functional activities are coordinated and delivered on time
• Organize and facilitate cross-functional meetings to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders