Senior Regulatory Project Lead - Global Submissions

Relay Therapeutics; Cambridge (MA); On-site; USD 150,000 - 214,000; Full time

Job summary

Relay Therapeutics seeks an experienced Regulatory Project Manager to support planning, coordination, and execution of global regulatory filings across our development portfolio. You will partner with Regulatory Affairs leaders and cross-functional teams to translate strategies into actionable plans and ensure alignment with major submission milestones.

In this role you will help build scalable PM processes, track timelines, manage risks, and drive timely delivery of submissions while supporting

Qualifications

• Bachelor's degree in life sciences or related discipline required; advanced degree preferred.
• 8–10 years in biotech/pharma with regulatory affairs or PM experience.
• Experience managing cross-functional regulatory submissions and development programs.
• Knowledge of regulatory submission planning and eCTD structure.
• Proficiency with tools like Smartsheet and Office Timeline.

Responsibilities

• Lead regulatory project management activities for assigned programs and major submission milestones.
• Partner with Global Regulatory Leads and cross-functional representatives to develop integrated submission and execution plans.
• Create, maintain, and communicate project timelines, critical path, milestones, risks, assumptions, and dependencies.
• Facilitate cross-functional meetings, submission working groups, and vendor interactions to drive accountability and timing.
• Monitor project progress and provide status reporting to regulatory leadership.
• Coordinate submission readiness activities to meet established timelines.
• Partner with functional reps to manage resource needs and workload forecasting.
• Drive issue resolution and escalation to maintain momentum.
• Contribute to development and continuous improvement of Regulatory PM processes and governance.

Skills

Regulatory project management

Cross-functional collaboration

Strategic planning

Risk management

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Smartsheet

Office Timeline

Job description

Relay Therapeutics seeks an experienced Regulatory Project Manager to support planning, coordination, and execution of global regulatory filings across our development portfolio. You will partner with Regulatory Affairs leaders and cross-functional teams to translate strategies into actionable plans and ensure alignment with major submission milestones.

In this role you will help build scalable PM processes, track timelines, manage risks, and drive timely delivery of submissions while supporting