Rupali Kumar Email & Phone Number

Us

Provided regulatory and clinical expertise to medical device companies, supporting FDA classification, market authorization, and compliance. Successfully executed traditional and special 510(k) submissions using FDA eSTAR, and prepared diverse regulatory submissions. Developed tailored regulatory plans, managed Trial Master Files, and collaborated with cross-functional teams for commercialization. Conducted clinical monitoring, managed patient budgets, and maintained data integrity across trials. Created clinical study documents, and maintained Electronic Data Capture programs (EDCs) for multiple clinical trials. Acquired certified training in clinical monitoring, demonstrating a commitment to regulatory strategy and efficient, compliant project execution.

Baltimore, Md, Us

Responsible for authoring a comprehensive Pre-Submission request document to the US FDA, ensuring adherence to regulatory guidelines and implementing effective document control practices.

Us

Involved in the preparation and submission of regulatory submissions, including 510(k)s, for clients. Developed effective regulatory plans through comprehensive research and analysis. Conducted literature searches for Clinical Evaluation Reports and contributed to the preparation and review of technical files. Efficiently managed document control using an electronic Document Management System. Acquired in-depth knowledge of ISO 13485:2016 through certified training.

Boston, Ma, Us

•Executed a strategic marketplace analysis for MedSapient to identify opportunities for digital healthcare communication solutions that enhance access to medication information for low health literacy and limited English proficiency patients.•Performed a comprehensive evaluation of current digital educational and symptom-tracking applications for Systemic Lupus Erythematosus and recommended a customized strategy to improve the overall functionality and user-friendliness of the app.•Collaborated with cross-functional teams to gather requirements and design the new app to meet the needs of patients with Systemic Lupus Erythematosus

Evanston, Il, Us

•Successfully planned and executed fundraising event, "Dhol Baje 2019," raising INR 100,000 for Asare, a nursing home for individuals with intellectual disabilities.•Implemented impactful awareness campaigns and community services, including dental hygiene camps and blood donation drives.• Demonstrated leadership abilities by effectively guiding a team of 18 council members and over 300 volunteers towards the successful execution of initiatives.

•Gained an understanding of best practices for monitoring vendor production, lead time, and performance in a hospital pharmacy setting.•Maintained organized and detailed records of pharmaceutical stock and sales, ensuring accurate inventory management and inventory control.•Assisted in dispensing and maintaining thorough records for investigational medications, ensuring compliance with regulatory requirements and standards.•Provided computer support for the pharmacy and other hospital departments, including printing reports, labels, and forms, contributing to the efficient operation of the organization.

•Demonstrated expertise in utilizing state-of-the-art laboratory equipment including HPLC, Gas Chromatography, UV-spectrophotometer, and LCMS, among others.•Contributed to quality control decision-making by reviewing and assessing procedures and specifications affecting product identity, strength, quality, and purity.•Conducted thorough quality control testing and analysis of oral formulations in accordance with GMP standards.•Collaborated with the Quality unit by providing support for the receipt and inspection of incoming product batches.•Compiled detailed trending reports to facilitate informed decision-making by upper management.•Facilitated effective record-keeping and preparation for audits by organizing batch records, SOPs, and other essential documentation.

Master Of Science - Ms, Regulatory Affairs (Quality Assurance And Compliance Concentration)

Bachelor Of Pharmacy - Bpharm

Senior School Certificate, Cbse, Medical

Secondary School Certificate, Cbse, Class 10 Boards