Global Regulatory PM Lead — Submissions & Strategy

relaytherapeutics

Cambridge (MA)

On-site

USD 150,000 - 214,000

Full time

6 days ago
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Job summary

Relay Therapeutics seeks a Regulatory Project Manager to orchestrate global filings and cross-functional plans for a growing portfolio. You will partner with Regulatory Leads to translate strategies into actionable submission timelines and drive adherence to deadlines.

You will help establish scalable PM practices, optimize processes, and coordinate readiness activities across programs, ensuring timely, compliant submissions and effective stakeholder communication.

Qualifications

  • Bachelor's degree in life sciences required
  • 8–10 years in biotech/pharma with regulatory/project management or drug development
  • Experience managing cross-functional projects supporting regulatory submissions
  • Knowledge of regulatory submission planning, eCTD structure, filing readiness
  • Ability to operate in a fast-paced, collaborative environment with competing priorities
  • Proficiency with PM tools like Smartsheet and Office Timeline

Responsibilities

  • Lead regulatory PM activities for development programs and major submission milestones
  • Partner with regulatory leads and cross-functional reps to develop submission/execution plans
  • Create, maintain timelines, critical path, milestones, risks and dependencies
  • Facilitate cross-functional meetings, submission work groups, and vendor interactions
  • Monitor progress and provide status reporting to regulatory leadership
  • Coordinate submission readiness activities and ensure timely deliverables
  • Manage resource needs, workload forecasting and prioritization
  • Drive issue resolution and escalation to maintain momentum
  • Contribute to PM processes, tools, metrics and governance

Skills

Regulatory PM
Cross-functional leadership
Project management

Education

Bachelor's in life sciences
Advanced degree preferred

Tools

Smartsheet
Office Timeline

Job description

Relay Therapeutics seeks a Regulatory Project Manager to orchestrate global filings and cross-functional plans for a growing portfolio. You will partner with Regulatory Leads to translate strategies into actionable submission timelines and drive adherence to deadlines.

You will help establish scalable PM practices, optimize processes, and coordinate readiness activities across programs, ensuring timely, compliant submissions and effective stakeholder communication.

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