Sumedha Sameer Bhokare
Regulatory Publishing Officer
Pimple Gurav
Summary
Accomplished Electronic Document Specialist & Regulatory Submission Publisher with 8+ years of experience in end-to-end regulatory documentation and global health authority submissions. Expert in advanced MS Word formatting, Adobe Acrobat, PDF QC, and eCTD publishing. Proficient in regulatory publishing tools and electronic document management systems. Strong track record of ensuring accuracy, compliance, and on-time submissions while effectively coordinating cross-functional teams including Regulatory, Clinical, and Medical Writing.
Overview
8
8
years of professional experience
Work History
Regulatory Publishing Officer
Productlife-group
04.2024 - Current
- Domain: Regulatory Operations
- Designation: Regulatory Publishing Officer
- Submission Publishing: Responsibilities: A. Binder creation in Veeva Vault 1. Binder creation in Veeva vault 2. Assigning documents into the binder and approving them. also, the approve the binder.
- B. Creation of Dossier 1. Creation of Dossier in Publishing Tool (eCTD Manager and Lorenz Docubridge) 2. Perform the document level publishing on documents like creating navigations like bookmarks and hyperlinks. 3. Create a new Dossier according to the HA requirements. Module 1 to Module 5. 4. Assigning documents into the module 5. Renaming documents according to the leaf title criteria. 6. Export the submission and validate the submission according to current eCTD validation criteria. 7. Validate the submission via eCTD manager and Lorenz eValidator. 8. Transfer the zipped package to the authority via eSubmission Gateways. C. Submission of Dossier via eSubmission Gateways 1. Submission via CESP, ESG-NextGen, EMA and MHRA Gateways.
- Document Publishing: As DS Coordinator, responsibilities include: Check the documents received from client on RA SharePoint. 2. Upload the documents from SharePoint to Veeva iDocs. 3. Allocate documents to team members. 4. Notify DS via Veeva iDocs using send as link option about the work allocation. 5. Update the tracker. 6. Confirm the deadline to client. 7. Inform the client once documents are formatted.
- As a Document Specialist, responsibilities include: 1. Check-out the document from Veeva iDocs. 2. Format the document using GEN014 and starting point tool. 3. Perform Technical checks of the formatted document. 4. QC of document (Self QC + Peer QC). 5. Check-in the document in Veeva iDocs. 6. Send for client review. 7. Update Tracker.
Senior Process Associate
Tata Consultancy Services
09.2018 - 03.2024
- Domain: Regulatory Operations
- Designation: Senior Process Associate
- Document Publishing: Responsibilities: Compliance check and publish the document. 2. Maintains full understanding of Non-Clinical, Clinical, CMC documents and Drug Safety report publishing, PDF Documents and Literature References. 3. Publishing of Regulatory documents i.e., Clinical Study Reports, Investigator Brochure, Clinical Protocols, Case Report Forms, Statistical Analysis Plan, Annual Reports, Literature references, PSUR, DSUR, SSUR, PADER, PBRER etc. 5. Maintains familiarity with publishing process of related standard operating procedures and work instructions. 6. Compliance check report documents according to the client specific PDF and MS word specific guidelines. 7. Performs quality check of published output for completeness and correctness with respect to navigation and standard PDF attributes required for submission in regulatory agencies. Verify that final customer and/or agency deliverables meet all applicable regulatory standard. 8. Ensures that the quality and TAT targets defined are always met. 9. Training and mentoring to new joiners. 10. To manage day to day planning of work to meet SLA.
- Clinical Study Report Publishing: 1. Publishing of Clinical Study Report (CSR) as per ICH e3 guidelines
- Submission Publishing: 1. Handling submission for promotion material (2253 submissions) for US.
- Document Specialist: 1. Handling the compliance report issues of regulatory word document and analyzing them with correct resolution.
Data Analyst
Sci-edge Abstracts
09.2017 - 09.2018
- Project Name - Drug Product Information (DPI): Analyzing pharmaceutical documents like medicine leaflets identifying and extracting the data of chemical reaction, indication of use, Direction for use and enter into software for data mining purpose. To identify subsection and cross-references of related documents.
Education
Master of Pharmacy -
Savitribai Phule Pune university
01.2017
Bachelor of Pharmacy - undefined
Savitribai Phule Pune university
01.2015
HSC - undefined
Maharashtra State board
01.2011
SSC - undefined
Maharashtra State board
01.2009
Skills
Technical Skills:
Adobe Acrobat Pro and PDF publishingISI Toolbox and Smart DeskLorenz e-ValidatorExtedo validatorVeeva Vault iDocs(Content Management and Publishing)Extedo eCTD ManagerLorenz DocubrigdgeInsight Publisher Insight ValidatorAdobe Acrobat Pro 11Basic knowledge of MS-PowerPoint, MS word and MS-Excel
Strengths:
Flexibility and AdaptabilityLearning agility: Quick learnerCritical thinking: Decision making skillsCoaching people: Teaching
Work: First Time Right
Timeline
Regulatory Publishing Officer
Productlife-group
04.2024 - Current
Senior Process Associate
Tata Consultancy Services
09.2018 - 03.2024
Data Analyst
Sci-edge Abstracts
09.2017 - 09.2018
Bachelor of Pharmacy - undefined
Savitribai Phule Pune university
HSC - undefined
Maharashtra State board
SSC - undefined
Maharashtra State board
Master of Pharmacy -
Savitribai Phule Pune university
Publications
- Formulation and development of sustained release pellets of venlafaxine hydrochloride, International Journal of Applied Research, 3(5), 793-799, 2017.
- Formulation and development of sustained release pellets of Metoprolol tartrate, World Journal of Pharmacy and Pharmaceutical Sciences, 6(6), 1553-1568, 2017.
Declaration
I hereby declare that the information furnished above is true to the best of my knowledge and belief. Also, I keenly look forward for an opportunity which is in tune to my expectations that puts me on the right platform to prove my credentials