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MBX Biosciences, Inc. · 11 hours ago

Associate Director, Regulatory CMC

Greater Boston

Full-time

Onsite

Lead/Staff

10+ years exp

MBX 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

Regulatory CMCGlobal submissionsGMP regulationsPharmaceutical developmentCross-functional collaborationRegulatory documentationOrganizational skillsCommunication skills

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™).

Founded in 2019

Carmel, Indiana, USA

11-50 employees

https://www.mbxbio.com

Funding

Current Stage

Public Company

Total Funding

$238.4M

Key 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

MBX Biosciences appoints Laurie Stelzer to board and audit committee chair

2026-01-25

legacy.thefly.com

MBX Biosciences appoints Laurie Stelzer to board of directors

2026-01-23

GlobeNewswire

MBX Biosciences Appoints Laurie Stelzer to Board of Directors as Audit Committee Chair

2026-01-22

Company data provided by crunchbase