Job Search Status
Open to workDesired start date: Immediately
Open To Work
Hi, I’m
Ravikiran Kashinath Hegde
Navi Mumbai
Work Preference
Summary
Skilled and experienced regulatory affairs professional with strong expertise in pharmaceutical submission publishing and regulatory compliance with overall 4.6 Years of experience in Regulatory Affairs-Submission Publishing with Comprehensive knowledge of US/ROW markets. proficient in using ORION, RED Compass, and various validation tools (RA-Submission Publishing) and Mentoring activity with Good Hands-on Safety tools. Adept at managing document archiving, regulatory tools,
and ensuring timely, quality submissions in accordance with global standards and internal SOPs.
I Value collaboration, learning, and excellence and eager to contribute to a diverse and dynamic team.
Overview
6
years of professional experience
Work History
Tata Consultancy Services
Submission Publisher / QC Reviewer
01.2021 - Current
Job overview
- As a QCer/Publisher at Tata Consultancy Services (TCS), I have handled projects on OPAR submissions and QC of various types of US region submissions markets with eCTD and CTD submissions including pre-publishing, publishing,
hyperlinking, compilation, validation and dispatch activities. - My role holds the responsibility of supervising submission which includes a publishing request from Initial phase to dispatch and archival into Repository.
- Participate in meetings as needed to ensure submission strategy is executed as required for project changes and communicated with project teams.
- Ensure all components are delivered and available as submission-ready components (fully bookmarked/intra-document hyperlinking for Table of Contents and Lists of Tables, Figures, Appendices, References, etc.)
- Review requirements for global submission via systems.
Review and validate submission for completeness against the agreed Table of Contents. - Manage the assigning of SUPPLIER resources to specific requests using system.
- Perform self-QC check, peer QC check of supplier-performed submission work (including validation against eCTD or non-eCTD specification).
- Perform QC check of larger, complex submissions managed by publishers.
- Send notification to the requestor and authors to review submission as necessary.
- Record errors in the quality metrics section of systems (track errors found in all QC and verification tasks including internal document, publishing, or plan errors as well as system/tool errors - excludes self-QC).
- Complete the Health Authority Application forms and submit to Health Authority via appropriate portal as required.
Copy submission to appropriate document repository and provide link within systems. - Build country-specific releases and re-publish when required.
Supply country-specific releases to local affiliates and partners, when required. - Archive completed submission within systems.
Padmaja Aerobiological Pvt. Ltd.
Chemist - Air Department
01.2020 - 12.2020
Job overview
- Conducted chemical tests for air quality (SO2, NO2, NH3 ambient & stack)
- Operated instruments including UV Spectroscopy and Stack Monitoring Kits
Education
KBP College, Vashi, Mumbai University
Bachelor of Science
01.2019
KBP College, Vashi, Maharashtra State Board
Higher Secondary Certificate
01.2016
ICL High School
Secondary School Certificate
01.2012
Skills
- Submission Tools: ORION, RED Compass, RISE Tool, ISI Toolbox, Adobe Acrobat, VeevaVault (Promomats), SPARS, REDS
- Software: Liquent Insight, MS Office (Excel, Word, PowerPoint)
- Validation: Various eCTD and non-eCTD validation tools
Documentation: Archiving, submission publishing, digital forms, hyperlinking, TOC generation - Knowledge of Medical Terms and Awareness about Good Clinical Practice (GCP)
- Regulatory Database Maintenance
- SharePoint Site Handling
- Time management
- Problem-solving abilities
- Documentation Accuracy
- Team collaboration
- Relationship building
Languages
English
Advanced (C1)
Marathi
Bilingual or Proficient (C2)
Hindi
Advanced (C1)
Timeline
Submission Publisher / QC Reviewer
Tata Consultancy Services
01.2021 - Current
Chemist - Air Department
Padmaja Aerobiological Pvt. Ltd.
01.2020 - 12.2020
KBP College, Vashi, Maharashtra State Board
Higher Secondary Certificate
ICL High School
Secondary School Certificate
KBP College, Vashi, Mumbai University
Bachelor of Science