Regulatory Publishing Expert

Job DescriptionAbout the Role:We are seeking a skilled eCTD Regulatory Document Professional to join our team at TransPerfect. As a key member of our regulatory publishing department, you will be responsible for preparing and submitting clinical study reports, IND documents, and NDA documents in accordance with ICH, eCTD, and other applicable electronic...

Description:Report directly to the Team Manager on all team and client issues, project work, project deliverables associated timelines, ensuring SLAs are satisfied and deliver reporting – daily, weekly, or monthlyPublish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable...

Description:Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standardsReport directly to the Team Manager on all team and client issues, project work, project deliverables associated timelines, ensuring SLAs are satisfied and deliver reporting –...

OVERVIEWThe Regulatory Publisher II is responsible for working with Regulatory Affairs to publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards, as well as to prepare, assemble and submit applications (IND/CTA/NDA/MAA/NDA, etc.) for submission...

OVERVIEWThe Regulatory Publisher I is responsible for working with Regulatory Affairs to publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards, as well as to prepare, assemble, and submit applications (IND/CTA/NDA/MAA/NDA, etc.) for submission...

Company OverviewWe are TransPerfect, a leading provider of language and content management solutions. Our team is dedicated to delivering high-quality regulatory publishing services to our clients.

OverviewAs a Regulatory Publishing Team Lead at TransPerfect, you will play a critical role in overseeing the team's daily work allocation, completion of tasks, and delivery to clients. With a strong background in eCTD regulatory publishing, you will be responsible for ensuring high-quality deliverables and meeting project timelines.

Description:Report directly to the Team Manager on all team and client issues, project work, project deliverables associated timelines, ensuring SLAs are satisfied and deliver reporting – daily, weekly, or monthlyOversee the task completed by a Junior Regulatory Publisher such as Publish Clinical Study Reports, IND documents, NDA documents, and other...

Attention Experienced Editor/Copyeditors! We are an innovative and expanding global publishing company in search of skilled and motivated Editor/Copyeditors to join our team for the ELA Program. About Us Alpha Publishing is a leading educational content development company based in Dubai, specializing in K-12 and higher education resources. Our mission is...

Responsibilities -Perform electronic submissions on ectd express for EU,USEH/US Submission via CESP gatewayISI Toolbox, CARA ETD eCTD express, CTD Regulatory Affaires Regulatory Publishing and SubmissionQualifications - B.pharma, M.Pharma, M.Sc

Responsibilities-Perform electronic submissions on ectd express for EU,USEH/US Submission via CESP gatewayISI Toolbox, CARA ETD eCTD express, CTD Regulatory Affaires Regulatory Publishing and SubmissionQualifications- B.pharma, M.Pharma, M.Sc

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Attention Experienced Editor/Copyeditors! We are an innovative and expanding global publishing company in search of skilled and motivated Editor/Copyeditors to join our team for the ELA Program. About Us Alpha Publishing is a leading educational content development company based in Dubai, specializing in K-12 and higher education resources. Our...

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About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon in US/Canada Market. This role is an exciting opportunity for individuals with experience in formulation regulatory affairs.Key ResponsibilitiesPrepare, review and submit ANDA/ANDS in the US Market, including modules.Contribute to life cycle management for...