Gopika Krishna
Coimbatore
Summary
Conscientious Regulatory Affairs Associate known for high productivity levels and efficient task completion. Specialize in regulatory submission strategies, compliance management, and documentation accuracy. Excel in complex problem-solving, strategic planning, and effective communication with stakeholders to ensure alignment with regulatory standards.
Overview
1
1
year of professional experience
1
1
Certification
Work History
Associate – Regulatory Affairs - EU – Documents & Information Management
VWR
Coimbatore
02.2023 - Current
- Managed regulatory documents for chemical and non-chemical products
- Coordinated team mailbox activities ensuring timely responses
- Provided operational support and collaborated with European stakeholders for regulatory clarifications
- Maintained and delivered regulatory assets for compliance
Training on Downstream Processing Technology
BiOZEEN
Bengaluru
- Acquired foundational knowledge in industrial filtration and chromatography techniques
Education
Master of Science - Biotechnology
Amrita School of Biotechnology, Amrita Vishwa Vidyapeetham
Kollam, KeralaBachelor of Science - Biotechnology
Amrita School of Biotechnology, Amrita Vishwa Vidyapeetham
Kollam, KeralaSkills
- Expertise in drug regulatory affairs (DRA) terminologies
- Advanced proficiency in MS Office Suite
- Familiarity with various document types (certificates of analysis, BSE/TSE statements, etc)
- Critical observation
- High adaptability
- Effective time management
- Stress resilience
- Strong teamwork capabilities
- International Regulations
- Pre-market submissions
- Agency liaison
- Validation procedures
- Data collation
- Change Management
- Material review
- Quality Management Systems
- Stakeholder Communication
- Document Management
- Data Gathering
- Regulatory Submissions
- Compliance Monitoring
Websites
Certification
Drug Regulatory Affairs (DRA) by Udemy
PROJECTS
MSc Dissertation Project
Effects of Dasatinib and Bafetinib on Breast Cancer Cells: Role of Lyn Kinase in Cell Proliferation and Migration
BSc BRITE Project
Analytical Study of Phytochemical Variations in Commercial Ayurvedic Products
Timeline
Associate – Regulatory Affairs - EU – Documents & Information Management
VWR
02.2023 - Current
Training on Downstream Processing Technology
BiOZEEN
Master of Science - Biotechnology
Amrita School of Biotechnology, Amrita Vishwa Vidyapeetham
Bachelor of Science - Biotechnology
Amrita School of Biotechnology, Amrita Vishwa Vidyapeetham
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