Hima Aravapalli

About Hima Aravapalli

As a MS in Regulatory Affairs graduate from Northeastern University, I am eager to apply my knowledge and skills in the regulatory domain for drugs, biologics, or devices. I have a strong background in pharmacy, having completed my PharmD degree. Prior to pursuing my MS, I worked as a research associate in competitive pharma intelligence at Cognizant Technology Solutions for 2.5 years, where I analyzed, processed, and updated global clinical trial data for oncology and cardiology segments, enabling the clients to make strategic, informed decisions. I maintained a high quality standard of 95% and handled client queries with timely and accurate solutions. I also gained experience in clinical research at Ramesh Hospitals, where I participated in IRB reviews, the informed consent process, data collection, and follow-up. I am a competent and motivated health care professional with excellent analytical, communication, and leadership qualities. I am looking for full-time opportunities starting in January 2024, where I can contribute to the clinical and regulatory objectives and goals of the organization while learning from industry experts and expanding my practical experience. If you think that my background and skillset are a good fit for your needs, please reach out to me at a••••••••@northeastern.edu.

Experience

1. Project Management and Operations

   Regeneron

   Feb 2024 — Present

   Develops and manages project plans, scope, timelines and deliverables aligned with business objectives.• Build live Power BI and Smartsheet dashboards, track KPIs, maintain RAID logs.• Leads cross-functional team including engineering, manufacturing, facilities, automation, IT, QA, and validation personnel through documentation, testing (IQ/OQ) and final GMP or production release.• Managing simultaneous validation and commissioning projects leading daily check-ins to clear dependencies to keep the critical path intact.• Keep all project artifacts—status reports, Gantt schedules, meeting notes—current in SharePoint/Smartsheet, ensuring complete transparency and accountability.• Deliver concise, early-warning status updates to leadership, elevating issues before they jeopardize timelines or deliverables.• Sync daily with peer PMs and functional leads, stepping in wherever gaps appear, coordinating through change-controls, coordinating vendor SCARs, or covering stand-ups to keep momentum steady.• Build resource-leveled Gantt charts (MS Project), Visio flows, and real-time Smartsheet views tailored for stakeholders from shop-floor leads to VP sponsors.• Familiarity with gene therapy, cell therapy, biologics, or drug development processes, FDA, EMEA, ICH, ISPE guidelines.

Education

• Jawaharlal Nehru Technological University, Kakinada

  Doctor of Pharmacy - PharmD, Pharmacy