Pankaj Bodhe

About Pankaj Bodhe

5 year experience in Submission publishing for US-FDA,EU- EMEA.ROW, GCC, Latam, Australia,Switzerland•Experience in submission publishing tool like liquent insight,insight publisher, global submit validator, lorenze validator,Eurs validator,veeva vault,citation wizard,z-zip file,nees checker bosnian,Roxio Creator.•Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.• Support Regulatory Affairs personnel in the coordination, preparation, and submission of all above submissions. • Responsible for the pre-publishing (Bookmarks and Hyperlinks), compilation, post publishing, Validation of Regulatory submissions and lifecycle management submissions. • Planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic formats. • Responsible for maintenance of all Regulatory and FDA correspondence (distributing, filing into electronic document management system) within specified time frames. documents required by the US FDA, EMEA and ICH. • Establishes relationships with customers; may meet rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments. • Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate. • May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development. • May represent on project team meetings, driving timelines and deliverables related to submission documents. Present to Customers on periodic status of the projects. • Acts as an SME/ expert in Regulatory knowledge in Publishing as applicable. May act as reviewer for regulatory SOPs, as assigned and appropriate. • Technical knowledge of electronic publishing systems and software (RIM Smart, Insight, Lorenz). • Proficiency with MS-Office Suite and Adobe Acrobat applications, Knowledge of insight publishing system• Self-starter with superior time management skills, and ability to work independently or in teams. • Performs other tasks or assignments, as delegated by Regulatory management.

Experience

1. Regulatory Affairs Global Submission Publisher

   ClinChoice

   Nov 2021 — Present · Bengaluru, IN