The Opportunity:
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.
Position requires weekly onsite presence
Your Role:
- You will serve as CMC-regulatory lead for assigned projects.
- Develop and execute CMC global submission plans and timelines in accordance with project goals
- You will lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmacetical Development teams
- You will be responsible for coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs teams.
- You will lead CMC-regulatory activities listed above with cross-functional teams and act as the regulatory CMC liaison between CMC, regulatory affairs and/or program management, as applicable.
- You will lead and manage regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, in conjunction and consultation with CMC leadership.
- You will keep abreast of regulatory guidance and technical/scientific developments relevant to projects.
Competencies for Success:
- 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/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 Background:
- 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
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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!
