Michelle Pires
Regulatory Writer @Precision BioSciences, Inc.
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WORK HISTORY
Regulatory Writer @Precision BioSciences, Inc.
As a regulatory writer, I am involved in analyzing and translating complex scientific data into succinct narrative. I am familiar with FDA and ICH regulations and guidelines and AMA style guide. I work with the CMC and regulatory teams to create and manage CMC documents for regulatory submission preparation including INDs and IND amendments. My responsibilities include -Drafting and managing technical reports focused on CMC, gene therapy and immuno-oncology-Conducting document reviews, managing project deliverables/timelines and the document approval process-Serving as a peer reviewer providing QC support for technical reports and various regulatory documents such as INDs, INTERACTs and briefing documents.
EDUCATION
Mumbai University
Bachelor of Pharmacy, 4/4
Northeastern University
Masters, Pharmaceutical Sciences (Pharmacology), 3.8/4
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