Associate Director, Regulatory Project Manager

Relay Therapeutics

Cambridge (MA)

On-site

USD 150,000 - 214,000

Full time

12 hours ago
Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Relay Therapeutics in Cambridge, MA is seeking an Associate Director of Regulatory Project Management to lead global regulatory filing programs. You will partner with Regulatory Affairs leaders and cross-functional teams to translate regulatory strategies into integrated, executable plans, ensuring on-time submissions and strategic alignment.

The role emphasizes building scalable PM practices within Regulatory, managing risk, and delivering governance processes to support a growing portfolio in

Qualifications

  • Bachelor's degree in life sciences or related field is required; advanced degree preferred.
  • 8–10 years of biotech/pharma experience with regulatory affairs and project management.
  • Demonstrated track record managing cross-functional projects supporting regulatory submissions.
  • Knowledge of regulatory submission planning, eCTD structure, and filing readiness.
  • Ability to operate in a fast-paced, highly collaborative environment with competing priorities.
  • Proficiency with PM tools and systems used for regulatory planning and execution.

Responsibilities

  • Lead regulatory project management activities for development programs and major submission milestones.
  • Partner with Global Regulatory Leads and cross-functional teams to develop submission and execution plans.
  • Create, maintain, and communicate timelines, critical path, milestones, risks, and dependencies.
  • Facilitate cross-functional meetings, working groups, and vendor interactions to drive accountability.
  • Monitor progress and provide status reporting to regulatory leadership and stakeholders.
  • Coordinate submission readiness activities and ensure deliverables meet timelines.
  • Manage resources, workload forecasting, and prioritization of critical activities.
  • Drive issue resolution and escalation to maintain momentum.
  • Contribute to PM process, tool, templates, metrics, and governance improvements.

Skills

Regulatory PM
Cross-functional leadership
eCTD knowledge
Smartsheet
Office Timeline

Education

Bachelor's degree in life sciences
Advanced degree preferred

Tools

Smartsheet
Office Timeline

Job description

Associate Director, Regulatory Project Manager

Cambridge, MA


The Opportunity

Reporting to the Executive Director, Head of Regulatory Project Manager, 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.


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 partsfearlessandrelentless, 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!


Voluntary Self‑Identification

For government reporting purposes, we ask candidates to respond to the below self‑identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.


As set forth in Relay Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.


If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:


A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.


A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.


An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.


An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Associate Director, Clinical Data Management
Associate Director, Clinical Data Management

Relay Therapeutics • Cambridge (MA)

On-site
USD 147,000 - 210,000
Director, Clinical Operations
Director, Clinical Operations

Relay Therapeutics • Cambridge (MA)

On-site
USD 250,000 - 400,000
Medical Science Liaison - Southeast
Medical Science Liaison - Southeast

Relay Therapeutics • Brewster Heights (NY)

Hybrid
USD 219,000 - 260,000
Associate Director, Regulatory Project Management
Associate Director, Regulatory Project Management

Relay Therapeutics • Cambridge (MA)

On-site
USD 150,000 - 214,000
Manager, Clinical Supply Chain
Manager, Clinical Supply Chain

Relay Therapeutics • Cambridge (MA)

On-site
USD 96,000 - 137,000
Director, Regulatory Project Management
Director, Regulatory Project Management

Mirum Pharmaceuticals, Inc. • Foster City (CA)

Hybrid
USD 230,000 - 250,000
Director, Clinical Sciences
Director, Clinical Sciences

Amylyx Pharmaceuticals • Cambridge (MA)

Remote
USD 214,000 - 241,000
Director, Clinical Operations
Director, Clinical Operations

Vir Biotechnology • San Francisco (CA)

On-site
USD 204,000 - 284,000
Principal Scientist, Formulation Development New United States - Remote
Principal Scientist, Formulation Development New United States - Remote

Praxis Precision Medicines, Inc. • United States

Remote
USD 170,000 - 190,000
Medical/dental/vision
Life insurance
401(k) match
+3
Scientific Narrative Lead
Scientific Narrative Lead

Praxis Precision Medicines, Inc. • United States

Remote
USD 190,000 - 220,000