MBX Biosciences
biotech
AssociateDirector,RegulatoryCMC
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“Associate Director, Regulatory CMC at MBX Biosciences. Skills: Regulatory CMC, CMC regulatory strategy, global submissions. support global Regulatory CMC activities. develop and author CMC sections”
What You'll Achieve.
enable successful global submissions; ensure that all Regulatory CMC deliverables meet global requirements; submitted to Health Authorities with the highest level of quality; support clinical development
Industry & Context.
Identify regulatory risks
What They're Looking For.
Must Have
support global Regulatory CMC activities
Nice to Have
proactive and detail‑oriented professional
What You'll Do.
support global Regulatory CMC activities
develop and author CMC sections
Evaluate changes to clinical trial materials
prepare the appropriate documentation
Identify regulatory risks
manage Regulatory CMC timelines
ensure timely submission
Deliver regular updates
Communicate CMC regulatory strategies
Represent the Regulatory CMC function
Contribute to regulatory process improvements
How You'll Work.
Team & Collaboration
Working closely with the Senior Director of Regulatory CMC; cross‑functional partners; Partner with internal stakeholders; Represent the Regulatory CMC function on cross‑functional project teams
Communication Scope
Deliver regular updates to senior leadership; Communicate CMC regulatory strategies, risks, and critical issues proactively
Process & Methodology
manage Regulatory CMC timelines and deliverables
Full Job Description
Position Summary MBX Biosciences is advancing a pipeline of innovative therapies designed to improve the lives of patients with endocrine disorders. We are growing our Regulatory Affairs organization and are seeking a proactive and detail‑oriented professional to support global Regulatory CMC activities across our clinical programs. This is an exciting opportunity to contribute to high‑impact development efforts within a fast‑moving, science‑driven biotech environment. In this role, you will support the development, execution, and maintenance of CMC regulatory strategies to enable successful global submissions and ongoing clinical development. Working closely with the Senior Director of Regulatory CMC and cross‑functional partners, you will ensure that all Regulatory CMC deliverables meet global requirements and are submitted to Health Authorities with the highest level of quality. Key Responsibilities Collaborate and provide support for Regulatory CMC activities across global clinical trials, ensuring adherence to regional requirements (FDA, EMA, APAC, etc.). Partner with internal stakeholders to develop and author CMC sections for regulatory submissions, including INDs, IMPDs/CTAs, NDAs, MAAs, and related amendments, as well as responses to Health Authority (HA) inquiries. Evaluate changes to clinical trial materials or manufacturing processes and prepare the appropriate documentation for regulatory updates or amendments. Identify regulatory risks, manage Regulatory CMC timelines and deliverables, and ensure timely submission of high‑quality CMC dossiers to support clinical development. Deliver regular updates to senior leadership on regulatory activities, submission status, and key milestones. Communicate CMC regulatory strategies, risks, and critical issues proactively to project teams and cross-functional stakeholders throughout the product lifecycle. Represent the Regulatory CMC function on cross‑functional project teams. Contribute to regulatory process impro
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