Bhavani Punati
Khammam
Summary
Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Associate-Global Regulatory Intelligence
Bhavani
Hyderabad
08.2022 - Current
- Created Reports Summarizing Data Related to Regulatory Issues
- Managed Regulatory Change Required by New and Revised Laws and Regulations, Communicating Complex Requirements and Identifying Operational Impacts
- Gathered and Analyzed Scientific Data to Formulate Explanations and Arguments for Regulatory Authorities
- Conduct Research and Analysis of Global Regulatory Requirements for Medical Devices/Medicinal Products, Food/Chemicals/ Cosmetics
- To Develop and Analyze the Data for Freyr Tools Such as Impact & IReady Cosmetics For News, Insights, Health Authority Communications
- Monitor Changes in Regulations and Guidelines Assess the Potential Impact on the Company Products, Clients and Provide Recommendations to Stakeholders
- To Build a Data Ingestion Pipeline, Capable of Data Updating and Data Handling, Review of Data ,Preparation and Reviewing of DFA Templates for Various Countries i.e.,ASEAB, USA, GCC, EU, Australia, Canada
- Proactive Regulatory Observance and Monitoring of Regulatory and Scientific Developments with Potential to Amend Regulatory Status Of Cosmetic Ingredients and Chemicals
Education
B.Pharmacy -
Malla Reddy Pharmacy College
Hyderabad04-2021
Skills
- Impact Assessment
- Risk Management
- ICSR, SAE Reporting timelines
- ICH-GCP Guidelines
- Clinical Trial Overview
- Data Management
Languages
Telugu
First Language
English
Proficient (C2)
C2
Certification
- ISEP Certification in Clinical Research, Pharmacovigilance and Regulatory Affairs.
Timeline
Associate-Global Regulatory Intelligence
Bhavani
08.2022 - Current
B.Pharmacy -
Malla Reddy Pharmacy College
- ISEP Certification in Clinical Research, Pharmacovigilance and Regulatory Affairs.
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