Krishna Tippana Mane
PharmD | Rph | Regulatory Affair Assistant (Clinical Trials)
- Role
- Regulatory Affairs Assistant (Clinical Trials) at PSI CRO
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Krishna Tippana Mane
Currently employed as a Regulatory Affairs Assistant (Clinical Trials) at PSI CRO, with…
Experience
Regulatory Affairs Assistant (Clinical Trials)
Apr 2024 — Present · Bengaluru, IN
As a Regulatory Affairs Assistant, I possess extensive experience in drafting and reviewing regulatory documentation, including Clinical Trial Applications (CTAs), Manufacturing License Applications (MLAs), and Test License Applications (TLAs). I ensure that all documents are accurate, complete, and comply with CDSCO regulations and standards throughout the preparation and submission process.Key competencies include: • Compliance and Quality Control: I ensure that all documentation aligns with CDSCO guidelines by applying quality control measures to guarantee consistency and accuracy, thereby supporting successful approval processes. • Collaboration: I work closely with both internal teams and external stakeholders to resolve queries, provide clarifications, and ensure smooth regulatory review processes. • Issue Resolution: I identify and resolve discrepancies in regulatory submissions to guarantee timely and accurate filings. • Document Management: I am proficient in managing document systems for versioning, organizing, and tracking regulatory materials throughout the submission lifecycle. • Communication with CDSCO: I act as the liaison for CDSCO communications, providing necessary clarifications and supporting the timely review and approval of applications. • Clinical Trial Insurance Compliance: I am well-versed in regulatory frameworks for clinical trial insurance, including indemnity and compensation requirements for trial-related injuries, and oversee insurance policy renewals to ensure continuous CDSCO compliance. • Additional Regulatory Affairs Support: I handle any other regulatory tasks as assigned, ensuring comprehensive and timely support for all regulatory affairs needs.This approach succinctly outlines my key responsibilities and skills while emphasizing my expertise in managing regulatory processes and compliance with CDSCO standards.
Education
Al ameen pharmacy college
Doctor of Pharmacy - PharmD
2015 — 2021
Rajiv Gandhi University of Health Sciences
Doctor of Pharmacy - PharmD
2015 — 2021
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