Note: The job is a remote job and is open to candidates in USA. MBX Biosciences, Inc. is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies. The Regulatory Affairs Fellow will work on projects across the Regulatory function, including Regulatory Science, Regulatory Chemistry, Manufacturing, and Controls, and Regulatory Operations, while also participating in professional development opportunities through Purdue University College of Pharmacy.
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
Skills
- 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
Benefits
- Eligibility to complete the Indiana Pharmacy Teaching Certification (IPTeC) Program
- Workshops for CV construction and mock Interviews
- MidWest industry Pharmacists Symposium
- Purdue reception at ASHP Midyear
Company Overview
MBX Biosciences, Inc. is a clinical stage biopharmaceutical company pioneering investigational Precision Endocrine Peptides (PEPs™). It was founded in 2019, and is headquartered in Carmel, Indiana, USA, with a workforce of 11-50 employees. Its website is https://www.mbxbio.com.
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