Vaibhav More
Shirpur
Summary
Detail-oriented Regulatory Specialist with experience in regulatory operations and documentation within the pharmaceutical domain. Skilled in regulatory data entry, compliance with ICH guidelines, and cross-functional collaboration. Strong foundation in document management, submission readiness, and quality control. Seeking to leverage regulatory knowledge and data management expertise in a Clinical Research Coordinator role to support clinical trial operations and ensure compliance with regulatory standards.
Overview
3
3
years of professional experience
Work History
Regulatory Data Specialist
Tata Consultancy Services (TCS)
02.2023 - Current
- Ensured timely and quality data entry updates in compliance with regulatory processes.
- Collaborated with cross-functional stakeholders to ensure accurate submissions of regulatory content.
- Supported change initiatives and contributed to process improvements for data management.
- Maintained compliance with ICH requirements, regional regulations, and organizational standards.
- Escalated and resolved issues related to regulatory data entry in a timely manner.
Education
Bachelor of Pharmacy -
Certificate in Clinical Research -
Skills
- Clinical Trial Documentation & Coordination
- Regulatory Submissions (eCTD, eTMF, Publishing)
- Knowledge of ICH-GCP & Regulatory Guidelines
- Data Entry & Quality Management
- Compliance & Audit Readiness
- Stakeholder Communication & Cross-functional Collaboration
- Issue Escalation & Problem Resolution
- Change Management & Process Improvement
- Data analysis
- Regulatory compliance
- Database management
- Quality assurance
Additional Information
Strong understanding of regulatory frameworks applicable to clinical research., Interested in transitioning into clinical trial coordination to apply regulatory expertise in patient-centered research.
Timeline
Regulatory Data Specialist
Tata Consultancy Services (TCS)
02.2023 - Current