Mansi Gupta Email & Phone Number

Boston, Ma, Us

• Trained in Good Documentation Practices (GDP), including preparation, review, and verification of batch records and other critical quality documentation.• Learned and applied Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP) to ensure compliance with quality standards and regulatory requirements.• Studied and practiced the creation and implementation of Standard Operating Procedures (SOPs) to support process consistency and quality control.• Gained expertise in Corrective and Preventive Actions (CAPA) to identify, investigate, and address deviations in quality management systems.• Developed foundational knowledge in biomanufacturing and biotechnology, focusing on processes aligned with GMP principles to support QA/QC roles.• Enhanced understanding of cGMP practices to prepare for quality assurance (QA) and quality control (QC) roles in the biotech and pharmaceutical industries.• Performed hands-on laboratory tasks, including sample preparation, testing, and data analysis, to support biopharmaceutical analysis.• Training in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) to ensure compliance with industry standards.

Got Selected in Nucleate’s Boston Activator 2025 Semi-Finalist as a Clinical Contributor

Boston, Ma, Us

• Provided comprehensive support to prospective students, ensuring timely tracking and communication of application status and required documents throughout the admissions process.• Utilized key business development platforms including Five9, Salesforce, ApplyYourself, Slate, and Microsoft Office Suite (Excel, Word, Teams) to manage and monitor application progress and facilitate smooth communication.• Assisted applicants in resolving queries, confirming missing documents, and offering step-by-step guidance through the application process.• Collaborated closely with the Enrollment Management team to streamline admissions workflows and ensure an efficient, applicant-friendly process.• Received hands-on training in enrollment management systems, enhancing proficiency in application tracking, data management, and communication strategies.

Boston, Ma, Us

• Secured IRB approval for SafeAI, enabling clinical deployment at Massachusetts General Hospital (MGH). • Conducted regulatory gap analyses to identify regulatory documentation and predicate devices for FDA 510(k) clearance of SaMD. • Researched FDA regulatory pathways to expedite approval and scalable deployment in large healthcare systems. • Performed regulatory research on AI in medical imaging, supporting commercialization and hospital integration. • Developed near- and long-term regulatory strategies to drive SafeAI’s U.S. market entry and growth. • Designed market entry strategies, including 510(k) clearance, competitor analysis, and revenue generation plans. • Streamlined clinical implementation and FDA submission processes for SaMD to ensure efficient approval and deployment.• Assisted in aligning product features with FDA SaMD guidance and ISO 13485 compliance requirements.• Suggesting next steps, including engaging in FDA meetings to align on regulatory requirements and advance the approval process.• Develops regulatory strategy for device approval in emerging markets.

• Conducted market and regulatory research, identified predicate devices, and defined the regulatory pathway for FDA 510(k) premarket notification, classifying SKEPSIS as a Class II Software as a Medical Device (SaMD) under FDA guidelines.• Ensured SaMD Compliance with ISO 13485:2016 (Quality Management Systems), ISO 14971:2019 (Risk Management), IEC 62304:2006/Amd1:2015 (Software Development Life Cycle), And ISO 14155:2020 (Clinical Investigation of Medical Devices).• Delivered comparative analysis of market competitors and outlined future directions for AI In Medical Device Technology.• Conducted basic research on regulatory requirements for medical devices In different markets (e.g., U.S. and EU), helping the team stay updated on new regulations.• Conducted research on FDA standards for AI in medical devices, focusing on compliance requirements for SaMD in the U.S. market.

• Responsible for maintaining all aspects of the site quality management. Managing all regulatory compliance activities, enforce Quality Assurance & Food Safety policies, and improving Quality Score covering Food Safety.• Responsible for the Implementation of Agro Food Industries Food Safety Policies and Quality Standards in the manufacturing facilities, warehousing facilities.• Enumeration and Identification of all foodborne pathogens: Performed total plate counts, isolation and identification of suspected pathogens as per standards.• Environmental monitoring of Aseptic & Non-Aseptic area: Settle plate method, Surface swab, air sampling from a different working environment• Performing third-party audits (SGS/INTERTEX) and maintaining regulatory authority’s inspections by implementing a corrective action plan• Verification and approval of QC/QA Records. Release of Finished Goods, control of Non-conforming products, and raw materials. Ensuring that all QA records, data & information are catalog in case of product recalls /traceability exercises to senior management.

Union, Nj, Us

• Managed regulatory compliance and quality assurance staffing for global healthcare clients, including top-tier pharmaceutical and biotech firms such as Takeda Pharmaceuticals, Abbott Laboratories, Medtronic, AstraZeneca, and PPD.• Drafted and developed comprehensive job descriptions for critical regulatory roles including Regulatory Affairs Specialists, Pharmacovigilance Scientists, EUMDR Regulatory Compliance Engineers, and Quality Assurance Engineers.’• Proactively identified and sourced top-tier regulatory and quality professionals through an in-depth understanding of pharmaceutical industry trends, emerging regulatory frameworks, and compliance needs, such as EUMDR and FDA regulations.• Ensured up-to-date knowledge of evolving global regulatory standards, including FDA, EMA, and EUMDR, enabling precise selection of candidates with critical expertise in pharmacovigilance, clinical research, and regulatory compliance.• Monitored industry trends and regulatory changes, advising clients on hiring strategies that align with evolving compliance frameworks, particularly in drug development and clinical trial processes.• Partnered with global pharmaceutical firms to oversee the recruitment of critical roles such as Medical Directors, Quality Assurance Managers, and Clinical Research Professionals, ensuring adherence to both international and local regulatory standards.• Played a key role in sourcing and onboarding professionals within regulatory affairs, quality control, and clinical trials management for various global pharmaceutical and healthcare clients. Ensured that candidates were well-versed in industry regulations such as FDA, EUMDR, and other global standards.

Gurugram, Haryana, In

New Delhi, Delhi, In

I completed my Industrial Training at Indian Farmers Fertiliser Cooperative Limited (IFFCO) under the Cooperative Rural Development Trust (CORDET) unit, focusing on the "Production of Biofertilizer from Rhizobium." During this period, I gained substantial expertise in biofertilizer production processes and techniques under the mentorship of Dr. H.M. Shukla.Key areas of training and expertise include:• Isolation Techniques: Learned advanced methods for isolating Rhizobium strains for use in biofertilizer production.• Selection and Identification: Gained proficiency in the selection and identification of suitable bacterial strains based on their effectiveness in nitrogen fixation.• Formulation and Packaging: Acquired hands-on experience in preparing liquid formulations of biofertilizers, as well as packaging techniques to ensure product stability and efficacy.• Storage and Shelf Life Management: Trained on best practices for storing biofertilizers to maintain their viability and effectiveness over time.• Microbiological Techniques: Practiced streaking and other microbiological techniques essential for quality control in biofertilizer production.

Master'S Degree, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs

Office Of Regulatory Affairs And Quality (Oraq) Training Program, Regulatory Affairs And Quality

Fundamentals Of Fda Clearance And Compliance, Regulatory Affairs (Medical Device)

Short Course, Machine Learning For Clinical Trials And Humanized Ai For Future Healthcare And Beyond

Bachelor'S Degree, B.Tech (Biotechnology)

Senior Secondary School, Biology/Biological Sciences, General

Higher Secondary School