Associate Director, Regulatory CMC

MBX Biosciences • Boston, MA

24d

About The Position

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.

Requirements

• BA/BS degree in Biology, Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field- MS preferred.
• 10+ years of pharmaceutical/biotech drug development experience in CMC development of NCEs / small molecules/biologics/combination products with 7+ years of direct regulatory CMC experience.
• Experience in leading CMC-related global submissions (IND, IMPD/CTA, NDA, MAA, etc.).
• Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
• Experience managing activities at external partners (CROs/CMOs) and driving cross-functional collaborations.
• Excellent written and verbal communication skills, including experience authoring regulatory documentation.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.

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 improvements and operational excellence initiatives.
• Other responsibilities as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level