Nived Kumar S
Chennai
Summary
Regulatory Compliance professional with expertise in Product License Maintenance and Global regulatory coordination. Skilled in managing NDA lifecycle activities, drug listings, PSUR SAR activities and labelling submissions in accordance with 21 CFR 314.81 guidelines. Proven ability to deliver professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Associate 2 - US Compliance and Data Science
Pfizer Healthcare India Private Limited
09.2022 - Current
- Manage the tasks associated with the A/NDA annual reports to continue to serve all Pfizer Businesses while maintaining the quality and compliance of all AR deliverables.
- Submission of a drug listing to guarantee compliance and life cycle management of US FDA registered drug products. submission of FDA-approved structured product labeling. distributing NDCs, updating the SPL and sending it, performing QC and Audit drug listing during launches, etc.
- Supporting in QC process of drafted Annual report to maintain and avoid errors to ensure compliance of the process.
- Used electronic technologies for submission tracking and documentation management.
- Performing SAR acitivity to support the gathering of responses for CFCs in which GRL compile a final response.
- Passionate about learning and committed to continual improvement.
- Delivered PSUR/SAR Call for contribution activity to meet the timelines.
- Delivered Product License Maintenance portfolio within strict timelines and quality standards.
- Monitored daily compliance dashboards; identified anomalies and escalated priority issues, contributing to improvement in issue resolution timelines.
- Collaborated on root cause analysis for compliance deviations; facilitated alignment meetings with stakeholders to outline resolution plans.
- Involved in Product Launch activities of the products under drug listing space for both brands and sterile injectables portfolio.
- Resolved problems, improved operations and provided exceptional service.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
- Contributed to continuous improvement initiatives for regulatory process, enhancing efficiency and compliance.
Education
Masters in Public Health - Biostatistics and Epidemiology
SRM University
06-2022
Bachelor's (Honors) - Allied Health Sciences
Sri Ramachandra University
Skills
- Regulatory Compliance
- Drug Listing
- PSUR SAR Activity
- Electronic Submission and technologies
- Attention to Detail and Quality Assurance
- ANDA/NDA/BLA lifecycle management
- Microsoft Excel
- Microsoft word and Power point
- Power BI
- Analytical thinking
- Training & Development
Certification
- IBM Data Science Professional Certificate
- Microsoft Office with AI
- Learning Data Governance
- Desiging Data Governance
Timeline
Associate 2 - US Compliance and Data Science
Pfizer Healthcare India Private Limited
09.2022 - Current
Masters in Public Health - Biostatistics and Epidemiology
SRM University
Bachelor's (Honors) - Allied Health Sciences
Sri Ramachandra University