Senior Manager, CMC Regulatory Expert

2 months ago

Cambridge, Massachusetts, United States Relay Therapeutics Full time
The Opportunity

We are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.

This position requires weekly onsite presence and involves leading the preparation, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA, and other global regulatory filings. You will also be responsible for coordinating responses to CMC questions/RFIs from regulatory authorities and leading CMC-regulatory activities with cross-functional teams.

Your Role

As a Senior Manager, CMC Regulatory, you will:

  • Develop and execute CMC global submission plans and timelines in accordance with project goals
  • Lead the preparation, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA, and other global regulatory filings
  • Coordinate responses to CMC questions/RFIs from regulatory authorities
  • Lead CMC-regulatory activities with cross-functional teams
  • Manage regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations
Competencies for Success

To be successful in this role, you will need:

  • A strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions
  • Proven ability to lead and manage regulatory CMC projects
  • 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/thru 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 Background

We are looking for a candidate with:

  • Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry, or related fields
  • Minimum of 6-8+ years of relevant experience in regulatory-CMC or within CMC function (e.g. analytical, formulation, and process development, QA, QC) in the biotech/pharmaceutical industry with a focus on CMC for small molecules
  • Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance
  • Knowledge of eCTD Module 3 and QOS requirements for INDs/IMPDs and NDAs/MAAs
  • Authoring experience of CTD Module 2 & Module 3 sections

We are a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. 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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