Dhatri PVL
Bengaluru
Summary
Self-motivated Regulatory Affairs Associate holding [Number] years of pharmaceutical industry work experience. Excellent project management abilities, including facilitation, organization and time management. Talented at providing regulatory leadership for new product development and change management activities.
Overview
10
10
years of professional experience
Work History
Regulatory-affairs
CIPLA
03.2017 - Current
- Collaborated with regulatory affairs peers and produced successful worldwide regulatory assessments and submissions.
- Managed creation and review of standard operating procedures and policy guidelines for regulatory affairs department.
- Gained knowledge and aptitude related to regulatory affairs and quality assurance, both domestic and international.
- Responded appropriately to local risks and opportunities arising from public affairs and regulatory issues across market.
- Responded to risks and opportunities arising from public affairs and regulatory issues.
- Performed quality control reviews of all loan packages to check adherence with federal and state regulatory requirements.
- Compiled and maintained paper and electronic records to meet regulatory guidelines and departmental quality assurance requirements.
- Consulted with regulatory representatives to manage filings, applications, and reports.
- Trained leasing professionals on regulatory requirements, company policies, and office procedures.
- Produced on-time communications in support of new product submissions for regulatory agencies.
- Assisted with data management for regulatory and operational reporting.
- Assisted with completion and submission of regulatory filings and other regulatory documentation.
Senior Executive
Dr. Reddys Laboratories Limited
03.2015 - 03.2017
- Participated in regular meetings with cross-functional teams to discuss progress updates, communicate concerns or challenges, and ensure alignment of project goals.
- Improved product reliability by executing rigorous test plans and ensuring software met established requirements.
- Streamlined QA processes for increased efficiency and reduced time spent on redundant tasks.
Quality Assurance Executive
Aurobindo Pharma Limited
01.2014 - 02.2015
- Managed a team of QA analysts, providing guidance and mentorship to ensure high performance levels.
- Led cross-functional teams to identify root causes of issues, driving continuous improvement efforts.
- Improved product quality by implementing rigorous testing procedures and standards.
- Collaborated with suppliers to ensure adherence to quality requirements, improving supplier performance ratings.
Education
Master of Pharmacy - Quality Assurance
Al-ameen College of Pharmacy
Bengaluru, India01.2014
Skills
- Compliance assurance
- Product Labeling
- Compliance Monitoring
- Submission preparation
Timeline
Regulatory-affairs
CIPLA
03.2017 - Current
Senior Executive
Dr. Reddys Laboratories Limited
03.2015 - 03.2017
Quality Assurance Executive
Aurobindo Pharma Limited
01.2014 - 02.2015
Master of Pharmacy - Quality Assurance
Al-ameen College of Pharmacy
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