Strategic Global Regulatory Project Lead

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

Job summary

Relay Therapeutics is seeking an experienced Regulatory Project Manager to support planning, coordination, and execution of global regulatory filings across the development portfolio. You will partner with Regulatory Affairs leaders and cross-functional teams to translate regulatory strategies into actionable plans that align with health authority milestones.

You will drive best practices, support operational excellence, and help build a scalable project management framework within Regulatory to

Qualifications

• Bachelor's degree in life sciences or related discipline.
• 8–10 years in biotech/pharma with regulatory affairs or project management experience.
• Experience managing cross-functional projects supporting regulatory submissions.
• Knowledge of regulatory submission planning and eCTD structure.
• Ability to operate in a fast-paced, collaborative environment.
• Proficiency with project management tools used for regulatory planning.

Responsibilities

• Lead regulatory project management activities for development programs and major submission milestones.
• Partner with Regulatory Leads and cross-functional teams to develop integrated submission and execution plans.
• Create and communicate comprehensive project timelines, critical path, milestones, risks, and dependencies.
• Facilitate cross-functional meetings and vendor interactions to drive accountability and decisions.
• Provide status reporting to regulatory leadership and key stakeholders.
• Coordinate submission readiness activities ensuring timely deliverables.
• Manage resources, workload forecasting, and prioritization of critical activities.
• Drive issue resolution and escalation to maintain momentum.
• Contribute to continuous improvement of Regulatory Project Management processes and governance.

Skills

Regulatory project management

Cross-functional collaboration

Biotech/pharma project management

Regulatory submissions planning

Education

Bachelor's degree in life sciences or related discipline

Tools

Smartsheet

Office Timeline

Job description

Relay Therapeutics is seeking an experienced Regulatory Project Manager to support planning, coordination, and execution of global regulatory filings across the development portfolio. You will partner with Regulatory Affairs leaders and cross-functional teams to translate regulatory strategies into actionable plans that align with health authority milestones.

You will drive best practices, support operational excellence, and help build a scalable project management framework within Regulatory to