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Details

Posted: 15-Oct-25

Location: Carmel, Indiana

Type: Fellowship

Salary: Open

Categories:

Pharmacy

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:

1. CV/resume

2. Cover Letter

3. Transcripts (unofficial is okay)

All application materials should be submitted via the application portal on the MBX Biosciences website: https://mbxbio.com/job-details/?gh_jid=4940832008 no later than November 7th, 2025. Please send any questions regarding the application to: RegFellowship@mbxbio.com.

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. 

About MBX Biosciences, Inc. - Purdue Regulatory Affairs Fellowship

Please see website for further information.

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