Shubham Hendre
Thane,India
Summary
- Looking to explore new fields opportunities
- Adaptable Submission Publisher with extensive experience providing first-class results. Meets job demands and deadlines through diligent work-ethic and dedication to quality.
- Proficiency in grasping concept such as Regulatory affairs (Document Publishing and Submission).
Overview
3
3
years of professional experience
4
4
years of post-secondary education
Work history
Document Management Specialist
Tata Consultancy Services
Thane, Maharashtra
07.2020 - Current
- Perform document management activities for regulatory submissions
- Document Publishing of Clinical Study Report (CSR), Risk Management plan (RMP), BD V-doc, Response V-doc, Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report(PBRER), License Renewals Safety Reports, Periodic Adverse Drug Experience Report (PADER). Safety Summary Reports (SSR), All clinical, safety and Regulatory Documents.
- Publishing of Clinical trial application (CTA). Search, Import and approve documents in compliance to submission ready standards, bookmarking, hyperlinking and other PDF properties as per HA guidelines using ISI toolbox.
- Creation of V-doc and initiation of required signature process for clinical and regulatory documents.
Train and review process related documents in document publishing group to attain process requirements. - Certified DMS Trainer responsible for training new team members in the processes and systems ensuring quality and smooth flow of activities
- Publishing and submission of IND SAE in eCTD format. Dispatching FDA Submissions via USFDA ESG gateway i.e. IND, NDA,BLA
- Reserving eCTD sequences prior to addition of documents and cross-checking it. Validation of compiled output by Lorenz e-Validator.
- Creating STFs and assigning documents as per Med watch, AoSE, Cover letter and Application forms(FDA 1571, 356h, 2253 etc.).
Education
Bachelor of Pharmacy - Pharmacy
Ashokrao Mane College of Pharmacy Peth- Vadgaon
Kolhapur, Maharashtra 08.2016 - 07.2020
Skills
- Publishing of redacted documents CTT
- Training and Mentoring
- Leadership and administration
- Communication and problem solving abilty
- Relationship building and management
- Well-organised and Quick Learner
- Regulatory Affairs, Regulatory Publishing and Submission
Languages
English
Intermediate
Technical Tools
- ISI Toolbox
- ANGEL CARA
- eCTD Express
- Lorenz e-validator
Timeline
Document Management Specialist
Tata Consultancy Services
07.2020 - Current
Bachelor of Pharmacy - Pharmacy
Ashokrao Mane College of Pharmacy Peth- Vadgaon
08.2016 - 07.2020
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