---
title: 'Associate Director/Director, CMC Regulatory at Relay Therapeutics'
canonical: 'https://feeny.ai/job/associate-director-director-cmc-regulatory-relay-therapeutics-cambridge-fxx1zz50mb8r'
type: 'job'
last_seen: '2026-10-13'
---

# Associate Director/Director, CMC Regulatory at Relay Therapeutics

- **Company:** Relay Therapeutics
- **Location:** Cambridge, MA
- **Posted:** 2026-09-10
- **Last confirmed live:** 2026-10-13
- **Apply:** https://job-boards.greenhouse.io/relaytherapeutics/jobs/6150448004

## Job description

As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.

Your Role:

- With minimal supervision, accountable for developing and leading the execution of regulatory CMC investigational, registration and/or post-approval strategies for Relay's development programs/products.
- Develop and execute CMC global submission plans and timelines in accordance with project goals
- Strong and deep foundational understanding of global RA CMC regulations and guidelines.
- Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance.
- Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations.  Strong analytical or process understanding that enables the development of robust and accurate submissions.
- Apply global regulatory CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Responsible for leading and coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs leads/SMEs.
- Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.
- Responsible for CMC-regulatory activities listed above with cross-functional teams and act as the regulatory CMC liaison between CMC/PD, regulatory affairs and/or program management, as applicable.
- Lead and manage CMC-regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, as applicable, in conjunction and consultation with CMC leadership.
- Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within PharmDev and Regulatory Affairs Teams, as appropriate.
- Keep abreast of regulatory guidance and technical/scientific developments relevant to projects.

Competencies:

- Strong background in CMC-regulatory affairs with focus on small molecule (preferably solid orals: tablets, capsules) clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions.
- Proven ability to lead and manage regulatory CMC projects independently. Able to deal with issues of critical importance with minimal supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management.
- In-depth knowledge of global CMC regulatory requirements and guidelines (e.g. FDA, EMA, ICH).
- Positive attitude, energetic and proactive.
- Strong technical writing and document review skills.
- Excellent organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
- Strategic thinking capabilities with forward looking perspective and ability to find solutions, in alignment with management and program goals, strong communication, planning, and collaboration skills
- Attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties.
- Ability to effectively manage multiple projects with competing priorities.

Your Qualifications:

- Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry or related fields.
- Minimum of 8-10+ years of relevant experience in regulatory-CMC and/or within CMC function (e.g. analytical, formulation and process development, QA, QC) in the biotech/pharmaceutical industry with a focus preferably on CMC for small molecules and oral solid products.
- Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance.
- Knowledge of eCTD Modules and QOS requirements for INDs/IMPDs and NDAs/MAAs.
- Experience managing submissions in RIM Veeva or equivalent; document formatting/Quality Control compliant with eCTD templates / requirements.

Estimated Salary Range: [$143,000 - $233,000].

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.

#JO1

## 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!

## About Relay Therapeutics

## Company Overview
- **One-liner**: Relay Therapeutics is a clinical-stage precision medicines company that uses its Dynamo® platform to visualize protein motion and drug previously intractable targets, with an initial focus on precision oncology and genetic disease.
- **Entity Type**: Public (NASDAQ: RLAY)
- **Headquarters**: Cambridge, Massachusetts, United States
- **Founded**: 2016
- **Founders**: Not publicly listed as individual founders; the company was launched by Third Rock Ventures.

## Core Business
- **Primary industry/industries**: Biotechnology, Precision Oncology, Genetic Disease Therapeutics
- **Target customers**: Patients with specific cancer mutations (e.g., PI3Kα, FGFR2, NRAS) and rare genetic diseases (e.g., Fabry disease, PROS); partners are healthcare providers, clinical trial sites, and regulatory bodies.
- **Mission or purpose statement**: "We aim to drug the undruggable." The company is laser-focused on bringing life-changing medicines to patients by visualizing protein motion to discover new therapeutics.

## Products & Services
- **Dynamo® Platform**: A proprietary drug discovery platform that integrates long-timescale molecular dynamics (MD) simulations, cryo-electron microscopy (cryo-EM), and other biophysical techniques to visualize protein motion and identify novel drug binding sites. This is the core technology enabling all pipeline programs.
- **Zovegalisib (RLY-2608)**: A clinical-stage, allosteric, pan-mutant and isoform-selective PI3Kα inhibitor. It is designed to overcome the toxicity of orthosteric inhibitors by sparing wild-type PI3Kα. Currently in a Phase 3 trial (ReDiscover-2) for HR+/HER2- PI3Kα-mutated advanced breast cancer and a Phase 1/2 trial for PROS and vascular anomalies.
- **Lirafugratinib (RLY-4008)**: A selective FGFR2 inhibitor. In December 2024, global development and commercialization rights were out-licensed to Elevar Therapeutics.
- **RLY-8161**: A first-in-class, NRAS-selective inhibitor designed to address the liabilities of pan-RAS inhibitors. Currently in a Phase 1/2 trial for NRAS-mutant melanoma and other solid tumors.
- **Fabry Disease Program**: An investigational non-inhibitory chaperone designed to stabilize the αGal enzyme without inhibiting its activity, potentially offering a chronic treatment option for Fabry disease. Currently in IND-enabling studies.

## Market Standing
- **Valuation/Market Cap**: $909.1 million (as of mid-2026) [linkedin.com](https://www.linkedin.com/company/relay-therapeutics-inc.)
- **Key Metric**: Annual Revenue of $15.4 million (pre-commercial, primarily from collaboration/grants) [linkedin.com](https://www.linkedin.com/company/relay-therapeutics-inc.)
- **Total Funding**: $1.8 billion (including IPO and follow-on offerings) [linkedin.com](https://www.linkedin.com/company/relay-therapeutics-inc.)
- **Notable Investors/Partners**: Third Rock Ventures (founding investor), Nextech Invest, Elevar Therapeutics (out-license partner for lirafugratinib).
- **Growth Signals**: Initiation of the Phase 3 ReDiscover-2 trial for zovegalisib in mid-2025; out-license of lirafugratinib to Elevar Therapeutics in December 2024; advancement of RLY-8161 into Phase 1/2 for NRAS-mutant cancers; expansion of the pipeline into genetic diseases (Fabry).

## Competitive Advantages
- **Dynamo® Platform Moat**: The company's core differentiator is its ability to use long-timescale molecular dynamics simulations to visualize protein motion. This allows them to drug targets (like allosteric sites on PI3Kα and NRAS) that are "undruggable" with traditional static-structure approaches.
- **Selectivity & Tolerability**: Their lead asset, zovegalisib, is designed to be a pan-mutant, isoform-selective PI3Kα inhibitor. This selectivity for mutant over wild-type PI3Kα is a key advantage over first-generation orthosteric inhibitors, potentially offering better efficacy and chronic tolerability.
- **First-in-Class Potential**: RLY-8161 is described as the first NRAS-selective inhibitor, addressing a major unmet need in NRAS-mutant cancers by sparing KRAS and HRAS, which are responsible for the toxicity of pan-RAS inhibitors.

## Strategic Focus
- **Advancing Late-Stage Pipeline**: The primary focus is on executing the Phase 3 ReDiscover-2 trial for zovegalisib in breast cancer and expanding its potential in vascular anomalies (PROS).
- **Expanding Pipeline**: Advancing RLY-8161 (NRAS) through Phase 1/2 and moving the Fabry disease program toward clinical trials.
- **Platform Validation**: Continuing to use the Dynamo® platform to discover new drug candidates for previously intractable targets, thereby validating the platform's broader potential beyond current pipeline assets.

## Why Work Here
- **Culture**: The company describes its culture as "highly integrated, collaborative and entrepreneurial." Employees emphasize that the team is "equal parts bright and bold" and that the work is a "personal mission" driven by a desire to help patients. The culture values candor, quirkiness, and sweating the details. [relaytx.com](https://relaytx.com/careers/)
- **Work Environment**: Based in Cambridge, MA (Kendall Square area). The company is on-site/hybrid, typical for a biotech R&D environment. The team is described as "world-class" and "highly integrated."
- **Notable Perks**: The company offers competitive benefits and perks, investing in employee well-being, financial health, and family support. [relaytx.com](https://relaytx.com/careers/)
- **Engineering & Science Culture**: The company emphasizes a highly collaborative environment where computational scientists (cheminformatics, computational architecture) work side-by-side with experimental biologists, chemists, and structural biologists. The focus on "protein motion" creates a unique intellectual challenge.

## Sources
1. [relaytx.com](https://relaytx.com/)
2. [relaytx.com](https://relaytx.com/pipeline/)
3. [relaytx.com](https://relaytx.com/careers/)
4. [linkedin.com](https://www.linkedin.com/company/relay-therapeutics-inc.)
5. [greenhouse.io](http://job-boards.greenhouse.io/relaytherapeutics)

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