Area of Expertise:
Monica provides regulatory; chemistry, manufacturing, and controls (CMC); and quality and compliance support to the pharmaceutical and biotechnology industries. She is experienced with authoring CMC sections of Investigational Medicinal Product Dossiers (IMPDs), Investigational New Drug Applications (INDs) and IND amendments, and Regenerative Medicine Advanced Therapy (RMAT) designation requests and meeting packages. Additionally, she has experience in change management as well as authoring Standard Operating Procedures (SOPs) and packaging and raw material specification sheets. Prior to joining SciLucent, Monica worked in Regulatory Affairs CMC in the biotechnology industry at a mid- to late-stage cell therapy company, where she supported the Regulatory Affairs CMC group to author, review, and coordinate regulatory submissions to the US Food and Drug Administration (FDA) as well as to global health authorities. Monica has a B.S. in Biology with Genetics and Developmental Option from Pennsylvania State University.