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Associate Director, Regulatory Project Management

Cambridge, MA

The Opportunity 

Reporting to the Executive Director, Head of Regulatory Project Management, you will support the planning, coordination, and execution of complex global regulatory filings activities across the development portfolio. You will serve as a strategic partner to Regulatory Affairs leaders and cross-functional teams, ensuring regulatory strategies are translated into integrated, actionable plans that support successful health authority interactions and major submission milestones. You will facilitate alignment across functions, proactively identify risks and dependencies, and ensure teams remain focused on critical deliverables and timelines. 

You will play a key role in advancing Regulatory Project Management best practices, supporting operational excellence initiatives, and helping to build a scalable project management framework within the Regulatory function to support the company's growing portfolio.  

Your Role 

  • Lead regulatory project management activities for assigned development programs and major regulatory submission milestones. 
  • Partner with Global Regulatory Leads and cross-functional functional representatives to develop integrated submission and execution plans. 
  • Create, maintain, and communicate comprehensive project timelines, critical path, key milestones, risks, assumptions, and dependencies. 
  • Facilitate cross-functional team meetings, submission working groups, and external vendor/partner interactions to drive accountability and decision-making, track commitments, and ensure execution against key submission timelines 
  • Monitor project progress and provide clear status reporting to regulatory leadership and key stakeholders. 
  • Coordinate submission readiness activities, ensuring deliverables are developed, reviewed, approved, and completed according to established timelines. 
  • Partner with functional representatives to manage resource needs, workload forecasting, and prioritization of critical activities. 
  • Drive issue resolution and escalation processes to maintain project momentum and minimize delays. 
  • Contribute to the development and continuous improvement of Regulatory Project Management processes, tools, templates, metrics, and governance practices. 

Your Background 

  • Bachelor's degree in life sciences or related discipline required; advanced degree preferred. 
  • 8-10 years of biotechnology, pharmaceutical, or related industry experience, including significant regulatory affairs, project management, or drug development experience. 
  • Demonstrated experience managing cross-functional projects supporting regulatory submissions and development programs. 
  • Knowledge of regulatory submission planning, eCTD structure, content development, and filing readiness activities. 
  • Ability to operate effectively in a fast-paced, highly collaborative environment with competing priorities. 
  • Proficiency with project management tools and systems used to support regulatory planning and execution e.g. Smartsheet, Office Timeline. 

Estimated Salary Range: [$150,000 - $214,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

#BP1 

About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.  

Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us! 

 

 

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