MBX Biosciences, Inc. · 15 hours ago
Associate Director, Regulatory CMC
Greater Boston
Full-time
Onsite
Lead/Staff
10+ years expMBX Biosciences is a clinical-stage biopharmaceutical company focused on innovative therapies for endocrine disorders. The Associate Director of Regulatory CMC will support global Regulatory CMC activities, ensuring compliance with regulatory requirements and overseeing the development of regulatory submissions for clinical programs.
BiotechnologyHealth CareTherapeutics
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
Qualification
Required
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
Company
MBX Biosciences, Inc.
MBX Biosciences, Inc. is a clinical stage biopharmaceutical company pioneering investigational Precision Endocrine Peptides (PEPs™).
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$238.4MKey Investors
Deep Track CapitalWellington ManagementFrazier Healthcare Partners
2024-09-13IPO
2024-08-05Series C· $63.5M
2022-11-14Series B· $115M
Leadership Team
P. Kent Hawryluk
President & CEO
Michelle Graham
Chief Human Resources Officer
Recent News
Longevity.Technology
2026-01-25
legacy.thefly.com
2026-01-23
2026-01-22
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