Regulatory Affairs - concentration - Clinical Research Regulatory Affa

Khevna Padhiar

**********@*****.*** 331-***-**** Boston, MA LinkedIn

SUMMARY

Extensive experience as a Regulatory Professional in Research, Analysis, Document Compilation, Compliance, Submissions, and Partnerships with Global Regulatory Authorities. Expertise in exercising strong regulatory skills for global pharmaceutical and medical device commercialization in the healthcare sector. A creative problem solver with the ability to effectively communicate and collaborate with different stakeholders from executives to individual contributors to help understand regulatory requirements and compliance issues for developing compliant solutions.

EDUCATION

Northeastern University Boston, MA

Master of Science in Regulatory Affairs - concentration - Clinical Research Regulatory Affairs Sep 2022 - Jul 2024

Coursework: Clinical Trials Optimization Designs Validation and Auditing Clinical Trial Regulatory submissions Regulatory strategy Human Experimentation Medical Device Development Benefit-Risk and Safety Reports (PBRER) Case Report Forms Corrective and Preventive Actions (CAPA) Risk Management Process Improvement.

Nirma University - Institute of Pharmacy Ahmedabad, GJ, India

Bachelor of Pharmacy Sep 2018 - Jun 2022

Coursework: Pharmaceutical Regulatory Science Computer Aided Drug Design Pharmaceutical Quality Assurance Quality Control and Standardization of Herbals Pharmacology Medicinal Chemistry Industrial Pharmacy Pharmaceutical Engineering Biostatistics and Research Methodology.

SKILLS

●Regulatory Compliance: U.S. Food and Drug Administration (FDA) - Federal Food, Drug, and Cosmetics Act (FD&C Act), Current Good Manufacturing Practices (CGMP), ISO 9001, ISO 13485, ISO 14971, 21 CFR (Code of Federal Regulations) - Part (312,314, 210, 211); European Medicines Agency (EMA) - ICH E2A, EU Regulations

●Submission Standards: Electronic Common Technical Document (eCTD), Drug Master Files (DMFs) and Documents, Change Control and Records.

●Quality Assurance: Quality Systems and Compliance, Non-conformance (NC), Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA), Standard Operating Procedures (SOP), Audit Support, Process Improvement and Documents, Change Control and Records.

Pharmaceutical Analytical Methods: High Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectroscopy (LC-MS), Gas Chromatography, Nuclear Magnetic Resonance (NMR) spectroscopy, Aseptics techniques, Quality Control Testing

●Technical: Avogadro (Cross-platform molecular editor), BIOVIA Discovery Studio Visualizer, ChemDraw (molecular editor), Microsoft 365, Adobe (Acrobat, InDesign)

PROFESSIONAL EXPERIENCE

Northeastern University, College of Professional Studies – Regulatory Affairs Co-op Boston, USA

Regulatory Affairs Intern (Crown Medical Research and Pharmaceutical Sciences College of Canada) Apr 2024 – Jul 2024

Successfully prepared various submission documents and used the CTD backbone to meet Health Canada’s validation criteria for the preparation of CTD submissions, ensuring full compliance with the Canadian and International regulatory standards.

Interpreted and applied ICH-M4, and Health Canada’s regulations, guidance documents, and policies, and used them to effectively prepare, compile, and format regulatory documents in accordance with regulatory guidelines ensuring compliance.

Demonstrated a comprehensive understanding of CTD requirements for Health Canada, enabling the development of a Regulatory Strategy and Quality Assurance processes for optimally preparing Clinical Trial Application in CTD format for submission to Health Canada.

Collaborated effectively within the team and other departments to coordinate the compilation of necessary documentation, data management and analysis, ensuring seamless information exchange and timely completion of regulatory submissions.

Proactively acquired and applied Regulatory Project Management skills, including the utilization of tools such as Gantt charts, to ensure efficient planning and execution of submissions in CTD format, resulting in streamlined processes and timely deliverables.

Zydus Lifesciences Ahmedabad, GJ, India Regulatory Intern Jun 2022 - Aug 2022

●Streamlined guidelines for post-approval changes (PAC) for the current marketing authorization holder in 14 countries, including the United States, the European Union, and various countries in Asia, Africa, and Latin America to reduce the average submission times by 30% which improved efficiency and compliance processes for the stakeholders of the company.

●Interpreted guidelines from 15 global health authorities and compiled them for the final submission in eCTD format by meticulous revisions which reduced the submission errors by 20%.

●Developed a submission tracker using Microsoft Excel to track the approval of documentation containing the PAC specific to each country which streamlined the regulatory filings from strategy to approval by 30%.

PROJECT WORK

Deficiencies in the Global Regulations of Medical Devices Ahmedabad, GJ, India Nirma University - Institute of Pharmacy Jan 2022 - Jun 2022

●Literature reviewed myriad journals and articles from Google Scholar to document the standard medical device regulations for the US, EU, and Indian industries by analyzing medical devices’ import/export challenges and referring to the Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF) guidelines.

●Leveraged advanced Microsoft 365 skills for meticulous data analysis and creation of comprehensive reports. Ensured clarity and accuracy in documentation of the project about the development and regulatory landscape of medical devices.

LEADERSHIP AND COMMUNITY INVOLVEMENT

●Creative Writing Workshop Member ‘23, Northeastern (NEU) Department of English, Boston, MA: Participated in group discussions, provided peer critiques, and gained fundamental insights into creative writing techniques which deepened my understanding of narrative structure and character development thus, enhancing my overall proficiency in writing.

●Volunteer ‘23, NEU Community Service and Civic Engagement, Boston, MA: Led a team to assist a non-profit St. Stephen’s Youth Programs on NEU Service Day to clean and beautify the organization’s ambience by painting the premises’ walls and cleaning up the building's rooms.

●Volunteer ‘22, Boston Book Festival, Cambridge, MA: Facilitated Mass Poetry’s event - six word story - by encouraging participant engagement which led to dynamic visibility in the festival.

●Volunteer ‘22, SEWA (Self Employed Women’s Association), Ahmedabad, Gujarat, India: Endorsed women workers’ (artisans, farmers and bakers) products launched at Gujarat State Handloom and Handicrafts Development Corporation Exhibitions by writing articles about them for internal publications which led to their 2x sales.

●State Basketball Player ‘15 - ’16, Mount Carmel High School, Ahmedabad, Gujarat, India: Won two Khel Mahakumbh championships at state basketball tournaments exemplifying teamwork and athletic excellence.

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