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MBX Biosciences, Inc. · 22 hours ago

Regulatory Affairs Fellow

United States

Full-time

Remote

New Grad

MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies. The Regulatory Affairs Fellow will work on various regulatory functions, including Regulatory Science, CMC, and Operations, while participating in professional development opportunities at Purdue University.

BiotechnologyHealth CareTherapeutics

Responsibilities

Assist in coordinating the preparation and submission of high-quality US and global regulatory documentation (eg, IND, CTA), ensuring compliance with applicable regulations and internal MBX standard operating procedures

Provide general operational oversight for ongoing Phase 1, 2, or 3 clinical trials by attending study team meetings, reviewing submission dossiers prepared by CRO partners, and performing standard study maintenance administrative duties

Work cross-functionally with research and development colleagues to develop informed Regulatory strategies for early and late-stage programs

Lead targeted research initiatives as Regulatory strategy questions arise throughout clinical development

Assist in tracking deliverables and following up with team members as needed to ensure project timelines are met

Maintain a current FDA commitments tracker in MBX’s electronic document management system

Participate in multifunctional CMC team meetings to help develop regulatory strategies

Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines

Support the creation and maintenance of CMC submission templates

Support routine and complex Regulatory submissions for US and Europe. Responsibilities include attending meetings, providing templates, formatting and publishing documents, and managing submission deliverable deadlines

Manage and archive submissions and correspondence in the Regulatory Information Management System

Monitor schedule and track Regulatory submissions to ensure corporate and health authority deadlines are met

Create and update Regulatory Operations process Checklists, User Guides, and Work Instructions