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MBX Biosciences, Inc. - Purdue Regulatory Affairs Fellowship
MBX Biosciences, Inc. - Purdue Regulatory Affairs Fellowship
Application
Details
Posted: 15-Oct-25
Location: Carmel, Indiana
Type: Fellowship
Salary: Open
Job Setting:
Academia
Pharmaceutical Science/Industry
Specialized Area: Medication Systems; Operations
Salary Details:
Competitive stipend
Reimbursement for professional travel expenses
Enrollment in Indiana Pharmacy Teaching Certificate (IPTeC) Program
Optional Purdue University benefits package
Health insurance
Prescription coverage
Vision plan
Dental
Vacation and University holidays
Required Education:
PharmD
The MBX Biosciences, Inc. (MBX) Regulatory Affairs Fellow position is being offered in collaboration with Purdue University through the College of Pharmacy’s Pharmaceutical Industry-Affiliated Fellowships Program. Over the course of 2-years, the PharmD Fellow will split their time between MBX (~ 90%) and Purdue University College of Pharmacy (~10%). While at MBX, the selected candidate will have the opportunity to work on projects and teams across the Regulatory function, including Regulatory Science, Regulatory Chemistry, Manufacturing, and Controls (CMC), and Regulatory Operations. The fellow will spend the first 18 months rotating throughout the different functions of the Regulatory Department and may choose to move to another MBX department (eg, Clinical Science, Medical Affairs, Drug Safety/PVG, Commercial, etc…) for a 6-month optional rotation pending management approval.
The Purdue University College of Pharmacy component of this fellowship will allow the selected candidate to participate in numerous networking and professional development opportunities each year. These include eligibility to complete the Indiana Pharmacy Teaching Certification (IPTeC) Program, workshops for CV construction and mock Interviews, the MidWest industry Pharmacists Symposium, a Purdue reception at ASHP Midyear, and more.
Key Responsibilities
Regulatory Science
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.
Regulatory CMC
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
Regulatory Operation
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
90% at MBX: In Office (Carmel, IN) or Remote (MA, NH, RI)
10% at Purdue University: West Lafayette, IN?
Doctor of Pharmacy (PharmD) degree from an ACPE accredited college of pharmacy (graduating in either 2025 or 2026).
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
Applications will open October 1st, 2025.
All interested applicants must submit the following via the application portal:
Interviews will be conducted on a rolling basis starting Mid-October.
Recognizing that the choice of a Post-Doctoral Industry Fellowship is an important decision, Purdue University College of Pharmacy, in conjunction with the Academic Industry Fellowship Alliance (AIFA), has agreed to extend offers for Fellowships no earlier than December 12th, 2025.