• Managed prescription drug submissions for the Pharmaceutical Drugs Directorate (PDD) throughout their regulatory life cycle• Assessed drug submissions for acceptability for review and provided regulatory recommendations to internal and external stakeholders

• Provided regulatory input to the Bureau of Pharmaceutical Sciences of the Pharmaceutical Drugs Directorate (PDD) on the acceptability of prescription drug submissions

• Screened drug submissions for prescription pharmaceutical products to ensure compliance with regulatory requirements

• Designed synthetic antibodies for research applications and therapeutic purposes using protein engineering methods.• Carried out genome scale knock-out screening in human cancer cells using CRISPR/Cas9• Experienced end-to-end in the antibody development process: from library design and construction, lead candidate identification by phage display screening, antibody production and characterization, affinity maturation for lead optimization, and candidate validation in efficacy assays

• Managed day to day activities of clinical studies to ensure activities were performed in accordance with Federal regulations, ICH guidelines, and GCP principles• Prepared all study-related material including the protocol and regulatory submission documents

• Developed a genetic screen to isolate cell cycle regulators using automated robotic systems.• Instrumental in the proper set-up of a new laboratory, delivered training to team members, and served as the point person for lab members.

• Lead scientific projects on signal transduction pathways deregulated in human cancer and metabolic diseases to identify critical regulators.• Implemented genomic and cell biology-based screening platforms, interpreted research data, assessed literature, prepared technical reports, presented at scientific meetings, and published research findings.