Regulatory Affairs Fellow

MBX Biosciences•Burlington, MA

7d•Hybrid

About The Position

The MBX Biosciences, Inc. (MBX) Regulatory Affairs Fellow position is a 2-year fellowship offered in collaboration with Purdue University through the College of Pharmacy’s Pharmaceutical Industry-Affiliated Fellowships Program. The selected candidate will split their time between MBX (~90%) and Purdue University College of Pharmacy (~10%). During the MBX portion, the fellow will gain experience across various Regulatory functions, including Regulatory Science, Regulatory Chemistry, Manufacturing, and Controls (CMC), Regulatory Operations, and Quality. The initial 18 months will involve rotations within the Regulatory Department, with an option for a 6-month rotation in another MBX department (e.g., Clinical Science, Medical Affairs, Drug Safety/PVG, Commercial) pending management approval. The Purdue University College of Pharmacy component provides networking and professional development opportunities, including the Indiana Pharmacy Teaching Certification (IPTeC) Program, CV and interview workshops, the MidWest Industry Pharmacists Symposium, and a Purdue reception at ASHP Midyear.

Requirements

Doctor of Pharmacy (PharmD) degree from an ACPE accredited college of pharmacy (graduating in either 2026 or 2027).
Excellent problem-solving skills, strategic thinking, and ability to work in a fast-paced, collaborative environment.
Outstanding interpersonal skills, self-awareness, and ability to work in different team dynamics.
Strong communication skills, both written and oral.
Proficiency in Microsoft Office Suite (MS Word, MS Excel, MS Powerpoint, etc.).

Responsibilities

Assist in coordinating the preparation and submission of high-quality US and global regulatory documentation (e.g., 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.
Support CQA reviews of project-related Clinical Operations/Development documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
Assist with the planning of clinical site audits and review of responses to resultant audit observations.
Participate in the compilation and analysis of quality metrics to drive GCP regulatory compliance.
Contribute to the preparation and organization of documentation and records supporting inspection readiness activities.