Immatics
Discovery of HLA-restricted tumor-associated peptides as cancer targets • Biomarkers • Immunomonitoring • Peptidomics & mass spectrometry • Standardized PBMC collection
201 - 500
Regulatory Affairs Manager
September 20
Immatics
Discovery of HLA-restricted tumor-associated peptides as cancer targets • Biomarkers • Immunomonitoring • Peptidomics & mass spectrometry • Standardized PBMC collection
201 - 500
Description
• The Regulatory Affairs Manager will be responsible for leading submissions for all projects in the US and will have oversight of the US regulatory submission processes and tasks. • Main responsibilities as submission lead include leading regulatory submission processes, ensuring compliance, managing regulatory document archiving, and interacting with external contacts. • Experience with e CTD and document management systems • Managing and directing DSUR reports, supporting data collection for project reports. • Communicating verbally, hearing, keyboarding, near visual acuity, sitting, and standing/walking are essential duties related to the job responsibilities. • Some travel is required - may require travelling domestically a few times per year or internationally once per year.
Requirements
• A bachelor’s degree (e.g., biology, chemistry or pharmacy) or • Minimum of 4-5 years of experience in Regulatory Affairs for pharmaceutical industry • Strong knowledge of global regulations and GxP quality guidelines • A master’s degree in regulatory affairs, a life science, or business administration is a plus • Experience with biological drugs and/or gene & cell therapy in oncological indications is a plus
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