Dr. Yasmeen Kaur, BDS

Lead global learning, compliance, and documentation excellence initiatives for multinational pharmaceutical and healthcare clients. Ensure all programs and materials align with Good Clinical Practice (GCP), regulatory compliance, and data integrity standards. • 🧩 Develop and implement enterprise-wide training programs integrating Regulatory Affairs, Quality Assurance (QA), and Compliance frameworks. • 📘 Collaborate with global leadership and cross-functional teams (Regulatory, Clinical, and QA) to design scalable learning strategies supporting regulatory documentation accuracy and inspection readiness. • 📊 Manage end-to-end project planning, risk assessment, and performance dashboards for regulatory learning operations. • ✍️ Author and standardise SOPs, Work Instructions, and Process Guides to align with evolving Health Authority expectations. • 💡 Partner with compliance and audit teams to build training content that reinforces audit readiness and regulatory excellence. • 🧠 Integrate continuous improvement methodologies and KPI reporting to track team compliance and submission performance. ✨ Key Achievements: • Delivered 15+ global training and compliance programs across the U.S., EU, and Canada with 100% on-time delivery. • Reduced new-hire onboarding and training completion times by 35% through streamlined learning workflows. • Strengthened documentation quality and team efficiency, improving inspection readiness scores by 25%.

Supported Regulatory Operations, RIM Systems, and submission documentation processes for global pharmaceutical clients, contributing to end-to-end regulatory submissions aligned with FDA, EMA, and Health Canada requirements. • 🗂️ Managed documentation lifecycle in Veeva Vault RIM, ensuring traceability, metadata accuracy, and submission readiness. • 🧾 Created and maintained Global Content Plans (GCPs), Submission Content Plans (SCPs), and Regulatory Objectives (ROs) for investigational and marketing applications. • 🧩 Applied theoretical knowledge of IND, NDA, and MAA frameworks to support dossier coordination and global regulatory submissions. • 📑 Authored and updated SOPs, templates, and regulatory work instructions to standardise document control and review processes. • ⚙️ Collaborated with Regulatory Affairs, QA, and Clinical Operations teams to ensure alignment with ICH, GxP, and Health Authority submission requirements. • 📈 Designed compliance dashboards and submission trackers to improve operational transparency and internal audit efficiency. ✨ Key Achievements: • Improved document accuracy and compliance by 30% through optimised metadata workflows. • Reduced regulatory rework by 25% by implementing automated review checklists. • Trained 15+ global users on RIM systems, increasing documentation consistency by 40%. • Supported multiple product submissions, resulting in zero audit findings during compliance inspections.

Supported pharmacy operations and ensured documentation integrity in alignment with Health Canada regulatory standards during the COVID-19 vaccination program. • 💉 Assisted with COVID-19 vaccination documentation, prescription verification, and medication labelling under strict compliance protocols. • 🧾 Processed prescriptions, maintained patient confidentiality, and documented adverse reactions for follow-up. • ⚕️ Collaborated with pharmacists and healthcare professionals to ensure complete documentation accuracy and patient safety. • 📋 Monitored medication inventory and ensured proper storage, documentation, and reconciliation. ✨ Key Achievements: • Maintained zero documentation or dispensing errors across all shifts. • Recognised for precision and compliance during large-scale vaccination rollout. • Strengthened audit readiness through consistent data entry and record validation.

Served as a key regulatory contact managing dossier preparation, product registration, and safety narrative authoring for pharmaceuticals, medical devices, and nutraceutical products. • 🧩 Supported global IND, NDA, and MAA submissions across APAC and EU markets, ensuring adherence to ICH E3 and client-specific standards. • 📄 Authored, QC’d, and finalised regulatory documentation, including Clinical Study Reports (CSRs), safety narratives, and Investigator Brochures (IBs). • ⚙️ Collaborated with Data Governance, ITS, and QA teams to maintain metadata accuracy in regulatory databases. • 🗂️ Coordinated document control, lifecycle tracking, and submission readiness for multi-regional product portfolios. • ✍️ Developed SOPs, templates, and quality checklists for regulatory documentation processes. • 🔍 Assisted in dossier gap analysis and Health Authority query management. ✨ Key Achievements: • Authored 100+ regulatory and safety documents with zero client revisions. • Supported 50+ product registrations across global regions. • Reduced document turnaround time by 25% through process and template optimisation. ________________________________________

Performed pharmacovigilance case processing, MedDRA coding, and safety data review for global studies, ensuring compliance with international regulatory requirements. • 🧠 Processed and triaged AE/SAE cases from spontaneous, solicited, and literature sources. • 📊 Ensured compliance with ICH E2A, CIOMS, FDA, EMA, and Health Canada PV guidelines. • 🔍 Maintained accurate, audit-ready documentation in ARGUS and AWARE systems. • 📈 Supported signal detection, data reconciliation, and case follow-up activities. • 🤝 Collaborated with safety physicians, data managers, and regulatory specialists to resolve case discrepancies. ✨ Key Achievements: • Processed 500+ safety cases with 100% regulatory compliance. • Supported global safety inspections with no major findings. • Improved case closure timelines by 20% through workflow streamlining.

Provided comprehensive dental care and managed clinic operations while ensuring compliance with healthcare documentation and patient safety standards. • 🦷 Delivered preventive, restorative, and surgical procedures while maintaining detailed patient records. • 📁 Developed and maintained documentation systems for treatment tracking, consent, and follow-up care. • 👩‍⚕️ Trained junior staff on patient documentation accuracy and procedural compliance. • 📊 Implemented quality control measures that enhanced operational efficiency and regulatory adherence. ✨ Key Achievements: • Achieved 95% patient satisfaction through consistent, compliant care documentation. • Reduced administrative errors and record duplication by 30% through digitized documentation practices.