● Requirement Management: Collected, evaluated, developed, documented, and effectively communicated requirements, ensuring a clear understanding among stakeholders. Supported user testing to validate requirements and ensure successful implementation.● Process Design and Standardization: Created workflows, approval processes, and validation guidelines tailored to meet internal stakeholder needs. Implemented standardized processes to monitor data quality and integrity across applications, ensuring consistent and reliable outcomes.● Requirement Gathering: Utilized a range of techniques including interviews, document analysis, requirements workshops, site visits, use cases, business process descriptions, and workflow analysis to gather comprehensive and accurate requirements, ensuring a thorough understanding of business needs.● Stakeholder Collaboration: Acted as a liaison between internal and external customers and software development teams, effectively communicating functional requirements, facilitating collaboration, and ensuring alignment between stakeholders.● Continuous Learning and Adaptation: Proactively monitored technical and regulatory changes, incorporating new knowledge and best practices into the preparation of business and specification documents, ensuring compliance and driving innovation.● Quality Assurance: Supported the delivery production line to ensure that deliverables consistently met business requirements and adhered to established quality standards, ensuring high-quality outcomes and customer satisfaction.

Identification of Medicinal Products (IDMP):● Enhanced Training and Development: Organize training on ISO IDMP standards, EU IDMP Implementation Guide, MedDRA dictionary, and controlled vocabulary.● Efficient Data Management: Implement automated tools for data cleanup and advanced analytical tools for gap analysis. Develop a user-friendly IDMP data collection repository.● OMS, RMS, and SPOR Activities: Provide training and guidelines for using the SPORIFY tool and handling OMS requests. Offer documentation and training on the PMS data model as per EU IG.● System Testing and Tool Utilization: Conduct regular system testing and training on EBX, RDM, and MDM systems. Develop procedures for SPORIFY mapping related to GDD cleanup.● Best Practices and Documentation: Collaborate with the DADI implementation team to create best practice documents. Establish and audit documentation standards for regulatory affairs activities.xEVMPD (Extended EudraVigilanceMedicinal Product Dictionary):● Automated Reminders and SOPs: Set up automated reminders and develop detailed Standard Operating Procedures (SOPs) to ensure timely and consistent xEVMPD data submissions and maintenance tasks.● Streamlined Data Management: Utilize templates for Excel and SmPC files, and implement a checklist for evaluating QC reports and 3rd ACKs received from the EMA.● Effective Query and Communication Management: Implement a system to log, track, and respond to EMA queries, and establish clear communication channels for Marketing Authorization Transfers and health authority interactions.● Comprehensive Training and Resources: Provide training on Veeva Vault, European guidelines, ICH requirements, and the use of SharePoint trackers, ensuring all team members are proficient and up-to-date.● Centralized Collaboration Tools: Use centralized trackers and collaboration tools for data mapping, dossier preparation, and submission planning to streamline processes and enhance teamwork.

● Automated Data Analysis and Verification: Implement automated tools for data analysis and verification of regulatory approvals and updates in the RIMS database to increase accuracy and efficiency.● Streamlined Product Registration: Develop a standardized process with clear guidelines for the timely registration of products, ensuring comprehensive tracking of lifecycle management activities to support batch release.● Lifecycle Management and Launch Tracking: Utilize project management software to streamline lifecycle management, track product launches, and centralize data handling.● Centralized Data Handling: Create a centralized database for all lifecycle management and registration activities, ensuring easy access and real-time updates.● Regular Training and Updates: Provide regular training sessions on new tools and processes, and keep the team updated on best practices and regulatory changes.