New · posted Oct 15
MBX Biosciences · Biotechnology
Regulatory Affairs Fellow
- Burlington, MA
- Hybrid
- Full-time
- Associate & Specialist
Open until filled
The role
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), Regulatory Operations, and Quality. 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.
What you need
Education & Qualifications
· 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.)
What you'll do
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 Operations
· 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
Clinical Quality Assurance (CQA)
- 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.
Pay and benefits
MBX Biosciences didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Indiana Pharmacy Teaching Certification (IPTeC) eligibility
Purdue networking and professional development opportunities
CV workshops and mock interviews
Rotations across departments
Purdue reception at ASHP Midyear
Where you'll work
Burlington, MAHybridOpen in Maps (opens in a new tab)
More jobs in Burlington, MAWorking conditions
Travel & Hybrid Expectation
You will be expected to travel periodically based on the needs of the business, including attendance at Together Weeks, Together Days, and functional meetings as requested by the team. Employees are expected to work on hybrid schedules, consistent with local office practices and the terms of the companies in office policy as in effect from time to time. The expectation is 3 days of in office time a week.
From the posting
About MBX Biosciences
MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs, and large potential market opportunities. The Company’s pipeline includes its lead product candidate canvuparatide (MBX 2109), in Phase
2 development for the treatment of chronic hypoparathyroidism (HP); imapextide (MBX 1416), in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, with an IND currently under FDA review, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
Equal opportunity, accessibility and legal noticesMBX Biosciences's statements, word for word
EEO Statement
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US27 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $75,500 | $90,000 | $95,250 |
Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not MBX Biosciences's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Regulatory submissions8
- Documentation and SOPs6
- GMP and compliance4
- Investigations and CAPA1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
MBX Biosciences on Regulatory Jobs
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Regulatory Affairs Fellow at MBX Biosciences
Open until filled.