About the role#
This 2-year Regulatory Affairs Fellowship is offered in collaboration with the Purdue University College of Pharmacy. You will split your time between MBX Biosciences (90%) and Purdue University (10%). The first 18 months involve rotations through Regulatory Science, CMC, Regulatory Operations, and Quality. You may choose to spend the final 6 months in another department, such as Clinical Science, Medical Affairs, or Drug Safety, pending management approval. This role includes opportunities for professional development through Purdue, including the Indiana Pharmacy Teaching Certification Program and industry-focused networking events.
What you'll do#
- Coordinate the preparation and submission of US and global regulatory documentation.
- Provide operational oversight for clinical trials, including attending study team meetings and reviewing dossiers from CRO partners.
- Work cross-functionally to develop regulatory strategies and lead targeted research initiatives.
- Maintain an FDA commitments tracker and track project deliverables.
- Participate in CMC team meetings and support the creation of submission templates.
- Format, publish, and manage regulatory submissions and correspondence.
- Create and update process checklists, user guides, and work instructions.
- Support clinical quality assurance reviews of development documents and assist with clinical site audit planning.
- Participate in the analysis of quality metrics and contribute to inspection readiness activities.
What you'll need#
- A Doctor of Pharmacy (PharmD) degree from an ACPE accredited college of pharmacy, graduating in 2026 or 2027.
- Proficiency in Microsoft Office Suite.
- Strong written and oral communication skills.
- Strategic thinking and problem-solving abilities.
- Self-awareness and the ability to adapt to different team dynamics.
- Interpersonal skills to work in a collaborative environment.
Location & details#
- Location: Burlington, Massachusetts.
- Work Modality: Hybrid, with an expectation of 3 days in the office per week.
- Travel: Periodic travel is required for functional meetings and company events.
- Status: Full-time, paid fellowship.
About MBX Biosciences, Inc.
MBX Biosciences is a clinical-stage biopharmaceutical company focused on endocrine and metabolic diseases. Founded in 2019, the firm develops Precision Endocrine Peptides to treat conditions such as obesity and chronic hypoparathyroidism. It operates from offices in Carmel, Indiana and Burlington, Massachusetts. The company currently employs 93 people.
How to get in at MBX Biosciences, Inc.
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