Associate Director, Regulatory CMC New Greater Boston Area
MBX Biosciences, Inc., Carmel, Indiana, United States, 46033
Overview
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 improvements and operational excellence initiatives. Other responsibilities as assigned. Education & Qualifications
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. Travel
You will be expected to travel periodically based on the needs of the business to the extent requested by the Company, including attendance at Together Weeks, Together Days, and functional meetings as requested by the Company. Company Overview
MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak‑to‑trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn. EEO Statement
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
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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 improvements and operational excellence initiatives. Other responsibilities as assigned. Education & Qualifications
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. Travel
You will be expected to travel periodically based on the needs of the business to the extent requested by the Company, including attendance at Together Weeks, Together Days, and functional meetings as requested by the Company. Company Overview
MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak‑to‑trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn. EEO Statement
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
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