Shraddha Shet

• Managed stakeholder expectations through transparent communication and timely status updates, ensuring alignment between project deliverables and business objectives.
• Collaborate with subject matter experts (SMEs) to collect and document business requirements for system and process improvements.
• Translate complex business needs into clear, actionable technical requirements to support the development and enhancement of business systems.
• Performed risk assessments on potential projects to determine feasibility and viability before moving forward with implementation plans.
• Analyze the current and future technological needs of the R&D functions, identifying gaps, opportunities for improvement, and recommending suitable informatics solutions to meet evolving business demands.
• Work closely with R&D teams to understand their challenges and align IT solutions with their long-term objectives.
• Lead efforts to optimize and design R&D functional processes by identifying inefficiencies and recommending process improvements.
• Implement system enhancements to streamline operations, increase productivity, and reduce operational costs.
• Oversee the design and implementation of processes and workflows, ensuring alignment with business goals and objectives.
• Assist the System Owner in creating solution designs and drafting functional specifications for new system implementations or process improvements.
• Formulate different SOPs in user-friendly language so that they are easily understandable to users.

• Built various submissions within Extedo eCTD Manager for NDA and IND applications.
• Compiled Investigational Medicinal Product Dossier (IMPD) submissions for Europe Market.
• Worked on the building, publishing, reviewing and compiling of electronic IND and BLA submissions including Annual Report, DSUR, New Protocols, Protocol Amendments, IND Safety Reports, PADER/PBER, Information Amendments, Investigator Brochures, and various other documents submitted routinely to the FDA.
• Developed and/or reviewed regulatory documents to ensure that all submissions are complete, accurate, and meet relevant requirements according to ICH and FDA guidelines.
• Ensured a streamlined process for publishing and document control by developing and maintaining procedures and authoring SOPs where needed.

• Handled compilation, verification, validation, life-cycle management of eCTD/NeeS dossiers for US, Europe and Canada.
• Reviewing the final documents as per the document standards and creating navigation in PDF documents using ISIToolBox and EVERMAP.
• Responsible for the final check and dispatch of the submission through ESG/CESP Gateway.
• Familiarity with Regulatory Operations (eCTD & NeeS) and Structured Product Labeling (SPL).
• Responsible for training and providing assistance to the new joiners.
• Liaise with the regulatory authorities to ensure timely assessment, linguistic review and approval, as applicable.
• Provide guidance on the country specific requirements and regulatory submissions to regulatory project teams.

• Compilation and Submission of Post Approval Submissions in eCTD as well as NeeS format, through CESP for Europe Market.
• Expert Core Dossier and Documentum user ensuring compilation of high quality electronic documents and dossiers for submission to regulatory authorities.
• Transitioned numerous paper submissions in eCTD format.
• Support and perform successful remediation for client's XEVMPD records that includes following deliverables-

Article 57 QC Evaluation.

• Manage information related to EVMPD (EudraVigilance Medicinal Product Dictionary)