Karingu Shiva Kumar
Regulatory Affairs & Compliance Specialist | Registered Pharmacist - Telangana Pharmacy Council | Pharmacy Council Of India |
- Role
- Regulatory Affairs & Compliance Specialist at Mushroom Solutions
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Karingu Shiva Kumar
With a solid foundation in healthcare. I am eager to leverage my skills, knowledge and passionate to contribute to the broader healthcare ecosystem from a non-clinical perspective. My 2 years of experience have given me a unique understanding of patient needs and healthcare operations. I\'m excited to explore new roles in healthcare administration, healthcare technology, healthcare consulting, or any non-clinical capacity where I can apply my insights to drive positive change and innovation in the industry. Let\'s connect to discuss potential opportunities and collaborations in this exciting journey.
Experience
Regulatory Affairs & Compliance Specialist
May 2025 — Present · Hyderabad, IN
Lead initiatives in Clinical Trial Management Systems (CTMS), ensuring seamless implementation and optimization of clinical workflows.Oversee Computer System Validation (CSV) for clinical software solutions, ensuring adherence to 21 CFR Part 11, GxP, HIPAA, GAMP5, and ALCOA++ standards.Provide strategic guidance on Regulatory Affairs and Pharmacovigilance, supporting compliance and operational excellence.Drive development and integration of Agentic AI solutions to enhance clinical trial operations and regulatory processes.Collaborate with cross-functional teams to translate complex clinical and regulatory requirements into scalable, compliant digital platforms.Ensure data integrity, traceability, and audit readiness across end-to-end clinical trial processes.Support protocol development, regulatory submissions, and study monitoring through innovative technology solutions.Implement process improvements to increase efficiency, reduce risk, and maintain the highest compliance standards.Provide training and mentorship to internal teams on system use, compliance requirements, and best practices.Contribute to the overall digital strategy, aligning clinical technology initiatives with organizational objectives and regulatory expectations.
Education
Gouthami Junior College (Nalgonda)
Intermediate, Bipc
2015 — 2017
Guru Nanak Institutions(GNI)
Bachelor of Pharmacy - BPharm, Pharmacy
Sunshine High School (Chandur)
SSC
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