Backed by NEA and Norwest.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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 activi ties
More about this role
Position Summary
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...
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