•Maintained responsibility as US Regional lead on four compounds including two small molecules, one tissue, and one cell therapy product across four therapeutic areas; and EU regional lead for one biologic product.•Led, prepared and submitted high-quality documentation for BLA, IND, and Orphan Drug Designation annual reports to global Regulatory Agencies within established timeframes.•Co-led the development and finalization of Pediatric Investigation Plans (PIPs).•Co-led internal patient-focused drug development (PFDD) efforts and incorporated patient insights into medical product decision-making. •Provided regulatory guidance for DSUR and CSR compilation and submission.•Conducted research and regulatory intelligence to define and contribute to the development of global competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks for global expansion.•Served as the European guidance expert for the organizations regulatory intelligence working group and contributed to compilation of the monthly newsletter. •Communicated project updates and risks to senior Regulatory management and key stakeholders.•Tracked regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions.•Supported Regulatory Agency meeting preparation including EOP2, teleconferences, information requests, and other health authority interactions.•Supported efficient integration, including organization and compliance check for documentation related to new product acquisitions and due diligence activities.•Maintained up-to-date knowledge on international and domestic regulatory requirements.•Initiated and contributed to the development of policies and procedures in alignment with GxPs, Guidance, and corporate objectives. •Proposed and initiated a Medical Affairs stretch assignment and completed training in field medical affairs as a medical science liaison.

· Preparation and submission of high-quality documentation for INDs, CTAs, NDAs, BLAs, MAAs, and related filings to Regulatory Agencies within established timeframes. · Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks.· Communicate project updates and risks to senior Regulatory management and stakeholders across the organization.· Track regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions.· Provide support for Regulatory Agency meetings, teleconferences, information requests, and other health authority interactions.· Support efficient integration, including organization and compliance check, for documentation related to new product acquisitions and due diligence activities.· Maintain up-to-date knowledge on international and domestic regulatory requirements.· Initiate and contribute to the development of policies and procedures in alignment with GxPs, Guidance, and corporate objectives.

•Supported regulatory activities for RETHYMIC, a tissue-based regenerative medicine, resulting in FDA approval of Enzyvant’s first commercial product. •Calculated patient-years of follow-up for RETHYMIC which was included at the top of the company’s press releases following approval.•Collected, organized, and analyzed regulatory intelligence information for 45+ regenerative medicine products in development. •Leveraged regulatory intelligence research findings, including precedent analyses, to contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. •Communicated regulatory risks and other findings related to industry trends to Enzyvant Quality Assurance, Clinical Development, Medical Affairs, Marketing, and Early-Stage Development.•Summarized newly published FDA draft guidance for internal review.

Dissertation Title: “Identification of functional pathways altered in testis by in utero exposure to low doses of Genistein and DEHP mixtures”• Identifies genes and pathways altered significantly by in utero exposure to genistein-DEHP mixtures utilizing microarray, RNA sequencing and qPCR• Identifies testicular cell types in which novel differentially expressed gene, Foxa3, is decreased by genistein-DEHP through the utilization of MALDI Imaging Mass Spectrometry, fluorescent in situ hybridization, immunohistochemistry, and laser capture microscopy• Examines Foxa3 regulation on downstream targets through utilization of protein studies• Studies epigenetic changes leading to Foxa3 downregulation induced by genistein-DEHP in utero exposure using ChIP sequencing• Presents findings in manuscripts, posters, seminars, and oral presentations

• Analyzed competitor landscaping of healthcare billing market • Identified value propositions of our client’s customers• Completed competitive analysis by conducting field studies HTCG is the only student-founded consulting organization specialized in the Health Tech industry at USC. We primarily offer services in the field of health economic modeling, branding strategies, and regulatory science consulting.

- Attended all course lectures for General Chemistry I and II-Facilitated at least two 60- minute small group study sessions per week throughout the duration of the semester -Hosted office hours 1-2 hours per week

• Assessed the cytotoxic effects of a lead compound and selected isomers in vitro using an androgen independent cell line• Presented findings in oral and poster presentations at the summer research symposium

• Conducted a retrospective clinical study on the patterns of prostate cancer progression after proton therapy via utilization of Vision Tree Optimal Care and MOSAIQ to code patient information• Assembled a Kaplan-Meier graph of the percentage of patients free from prostate cancer progression