Associate Director, Regulatory CMC

Benefits

Parental leave

Not verified

Non-birth-parent leave

Not verified

Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

Not verified

Relocation assistance

Not verified

Childcare support

Not verified

Learning budget

Not verified

Verification

Not verified

Salary

Not verified

401(k) match

Not verified

Was this benefit information wrong? Tell us.

Schedule

Shift type

Not verified

Weekend work

Not verified

Application

Cover letter

Not verified

Assessment

Not verified

Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Associate Director, Regulatory CMC Greater Boston Area 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

Read the full description at mbxbio.com. FewerJobs shows a source-linked preview and links to the original posting.