• Supported Regulatory Affairs department in delivering core services to meet Global Regulatory Affairs business objectives, including electronic document management, Regulatory submission, pre-publishing, data intelligence, and tracking activities.
• Assisted submission delivery team in meeting market-specific requirements.
• Supported and consolidated Regulatory Project Teams' Planning and Tracking for assigned projects/products.
• Managed Pre-Publishing activities within the company’s electronic document management system and the Regulatory Information Management System.
• Facilitated communication between Local Operating Companies and Global Industrialization Operations to ensure Regulatory status sharing and business continuity.
• Conducted ad hoc refresher training for colleagues on utilizing company tools and systems effectively.
• Provided technical advice and support for electronic submission build and delivery, including eCTD configuration, lifecycle management, and conversion to maximize reuse.

• Spearheaded eTMF Business Process ownership, establishing and maintaining the vision and roadmap for a compliant organization.
• Led special projects in eTMF, including KPI and Metrics development through Spotfire, Data Migration strategy, and process improvement.
• Served as the key interface between Senior Management, end-users, and IT groups.
• Directed quality practices, management monitoring, control document development, improvement, and training support.
• Coordinated with Head TMF Management to drive change and communication initiatives for TMF implementation, business intelligence, and compliance.
• Developed and maintained SOPs and Written Standards, focusing on organizational change and continuous improvement.
• Managed TMF reference models and frameworks for Inspection readiness.
• Led various Stakeholder management activities.
• Designed, analyzed, and reported data and information trends to Senior Management.
• Acted as a change agent by sharing the latest advancements in GCP and regulatory requirements with stakeholders.

• Successfully planned, implemented, and executed assigned clinical projects
• Oversaw and managed clinical project development to ensure data quality and integrity
• Provided guidance and reviewed scope of work, objectives, timelines, and quality of deliverables for studies
• Assigned and directed work, appraised performance, guided professional development, and addressed employee relations issues
• Coached and mentored employees on project planning, review, risk management, and problem-solving
• Identified and proposed strategies to prevent or correct unusual or significant risks in clinical projects
• Identified skill and competency gaps at individual level and crafted development plans to close them
• Collaborated with management to proactively identify project and individual needs and resourcing solutions
• Ensured project budgets met financial goals and adherence to change control processes
• Facilitated hand-off and kick-off meetings to identify risks and develop contingency plans
• Reviewed project profitability and supported continuous process improvements
• Participated in corporate initiatives, special projects, and served as client liaison or cross-functional liaison within department.

• Collaborated closely with functional team and Project Manager to ensure deliverables in accordance with SOPs, WIs, and TMF plan.
• Ensured clinical trial documentation consistency with Trial Master File Specifications, SOPs, ICH-GCP guidelines, and regulatory agencies requirements.
• Provided consistent setup and maintenance of TMF requirements, processes, and programs.
• Assisted with internal and external audits, developing CAPA related to TMF findings.
• Reviewed data quality outputs and audit outputs to identify trends per study and across programs, with the overall objective of TMF being submission and inspection ready at all times.
• Developed and assisted with the implementation of TMF specifications, including Regulatory packet requirements and mapping of TMF index with latest DIA RM periodically.

• Prepared and reviewed regulatory submissions for Product Renewals, variations, and PSURs by liaising with internal and external clients, tracking project plans, and providing status updates in submission tool.
• Tracked Product life cycle maintenance for a client.
• Provided project-specific regulatory technical expertise and coordination oversight for key client projects, directing other GRAs as needed.
• Collaborated extensively with stakeholders within the company, clients, and regulatory authorities.
• Assisted in identifying and addressing out-of-scope activities in contracts, liaising with line manager to manage contract modifications including project budgeting, forecasting, and risk management.
• Served as the single point of contact for obtaining GMP and COPP certificates globally.

• Managed study startup & set-up activities, including filling of documents, collection, review, submission, QC, archival & processing of essential documents to maintain up to date & complete TMF as per client, ICH-GCP and regulatory requirements.
• Prepared and coordinated submissions to ethics and other bodies.
• Provided country specific Study Start Up expertise to Study Start Up Team Leads and project teams through effective oral & written communication among all project team with resolving and/ or transmitting messages of problems.
• Conducted feasibility, site identification, site contract negotiation, and other study start up activities, as assigned.
• Collected critical documents required for IP Release.
• Supported PM for various tracking activities for site initiation and regulatory binder submission.
• Provided support for identifying and mitigating risks & for internal and external audit along with generation of CAPAs.

• Developed study documents for CROs, including informed consent forms, case report forms, site selection materials, IB updates, and other essential project-specific documents
• Planned and managed all clinical study supplies to support the execution of clinical projects, including distribution of documents, forms, logs, supplies, equipment, and investigational products
• Provided training on project-specific and GCP requirements to new staff including Study Coordinators, Project Team members, and Investigators
• Motivated investigators to achieve patient recruitment targets and completed accurate study status reports
• Supported the development and review of ICFs, Protocol summaries, and IBs, ensuring timely submission for ethics/IRB approval
• Conducted and supported Pre-study visits, Site initiation visits, regular monitoring visits, and close-out visits for sites
• Reviewed and submitted Monitoring visit reports into the client system within appropriate timelines and followed up on outstanding issues
• Conducted IP accountability and reconciliation activities at sites
• Performed source data verification at sites to ensure data capture in accordance with guidelines, SOPs, and GCP requirements
• Participated in P2 and P3 trials for Gastrointestinal, Inflammatory, and Infectious diseases.

• Engaged in TAU’s Extensive Research curriculum program for PhD in Clinical Research, acquiring knowledge in didactic coursework and practical research areas of Clinical & Transnational Research.
• Studied Biomedical-Patho-physiological Basis of Diseases, Pharmacology, Drug discovery and development, Regulatory & Ethical Aspects of Clinical Trials, Clinical Data Management, Pharmacovigilance, Quality Control, Audit and Inspection in Clinical Trial, Medical writing/Reporting, PK, BA, BE in Clinical Trials, Molecular Biology, Biotechnology, Pharmaceutical Biotechnology, Computer Aided Drug Designing, SAS Programming & Epidemiology.
• Participated in Systematic Literature review, Meta-data analysis projects, Data collection, Data mining, Text mining, Data Analysis, Data collation, Data Review, Critical appraisals, assignments, and publication and presentation of research paper in an International journal.

• Acquired a comprehensive understanding of the scientific requirements of drug discovery and clinical research in various settings (pharmaceuticals, devices, diagnostics, natural products, etc.).
• Applied ethical and regulatory principles to all research projects.
• Demonstrated knowledge of the reliability of medical evidence obtained through various approaches and critically evaluated experimental designs.
• Interpreted, critiqued, and applied information from medical publications.
• Effectively communicated complex scientific data orally and in writing to diverse audiences, including the medical profession, regulatory authorities, media, and patients.
• Successfully undertook an individual research project by applying principles of experimental design, data collection, analysis, and critique.

Clinical Research Management

• Dedicated volunteer at BAPS organization, providing compassionate service to those in need.
• Passionate about making a positive impact in the community through volunteer work.
• Committed to supporting and assisting individuals in various capacities.
• Honored to be part of such a reputable and impactful organization like BAPS.