Regulatory publisher ii
24 hours ago
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 monthly Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, e CTD, and other applicable electronic publishing standards Develop a thorough understanding of all aspects of the publishing software, tools, process, and output requirements Perform e CTD readiness/pre-publishing tasks (i.e., formatting, bookmarking, and document navigation) Perform tasks within the publishing system (creating e CTD submissions; lifecycle management; assigning documents; adding cross-references hyperlinks) Complete high-quality submissions following regulatory guidelines and internal processes within timelines Ensure consistency across regulatory submission documents following the regulatory style guide Perform publishing QC tasks within the electronic publishing system and QC of the published output to ensure high submission quality Perform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution Maintain knowledge of current regional regulations in regard to application format Understand, interpret, and apply Agency regulations and guidelines related to e CTD submissions Dispatch submissions to Regulatory Authorities via agency portal, through customers or directly Build a good working partnership with Service Desk and Solutions Engineering Teams to ensure efficiency for project deliverables and timelines are adhered and SLAs are kept Participate in submission team meetings to plan and track submissions and relevant documents as assigned Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor Required Skills: Demonstrate attention to detail Ability to successfully train & learn under the more advanced Specialists on how to conduct all quality assurance reviews in the specified areas Ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe Strong communication and organisational skills, as well as a high level of proficiency with problem-solving, conflict resolution, negotiation, and team-building skills Highly proficient computer skills including Adobe Acrobat DC and MS Word, Electronic submission software, Windows and MS Office (Outlook, Word, Excel, Power Point, Share Point) or similar software Ability to work under deadlines to meet project timelines, including the ability to modify work schedules when needed Demonstrated ability and willingness to learn new products and processes independently and quickly Required Experience and Qualifications: Minimum Bachelor’s degree or its equivalent 3-4 years of experience in e CTD Regulatory Publishing required Direct knowledge of or willingness to learn e CTD publishing tools Problem-solving abilities and adaptability Technical writing and documentation knowledge Strong technical aptitude Confidence and assertiveness; professional attitude and demeanor Desired Skills and Experience: Strong attention to detail, organization, multitasking, project management, teamwork, and communication skills Adaptable / Flexible approach to work Self-starter with excellent organization and time management skills Result-oriented, biased to action
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Regulatory publisher ii
24 hours ago
India TransPerfect Full timeOVERVIEW The 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, e CTD, and other applicable electronic publishing standards, as well as to prepare, assemble and submit applications (IND/CTA/NDA/MAA/NDA, etc.) for...
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TransPerfect | Regulatory Publisher II
2 days ago
india TransPerfect Full timeOVERVIEWThe 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...
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TransPerfect | Regulatory Publisher II
23 hours ago
india TransPerfect Full timeOVERVIEW The 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...
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Regulatory Publishing Specialist
2 days ago
India TransPerfect Full timeJob 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...
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Senior regulatory publisher
24 hours ago
India TransPerfect Full timeOVERVIEW The Senior Regulatory Publisher is responsible for working with Regulatory Affairs to publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, e CTD, and other applicable electronic publishing standards, as well as to prepare, assemble and submit applications (IND/CTA/NDA/MAA/NDA, etc.) for...
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Regulatory Publishing Expert
2 days ago
India TransPerfect Full timeAbout the Role">This is a highly specialized position within our team, focusing on regulatory publishing for clinical study reports. The successful candidate will have a deep understanding of eCTD submissions and be able to work independently, prioritizing tasks and meeting deadlines.">Key Responsibilities">Publishing clinical study reports, IND documents,...
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TransPerfect | Regulatory Publisher
2 days ago
india TransPerfect Full timeDescription: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 –...
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TransPerfect | Regulatory Publisher
23 hours ago
india TransPerfect Full timeDescription: Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards 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...
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Team lead, regulatory publisher
24 hours ago
India TransPerfect Full timeDescription: 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 monthly Oversee the task completed by a Junior Regulatory Publisher such as Publish Clinical Study Reports, IND documents, NDA documents, and other...
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TransPerfect | Regulatory Publisher I
2 days ago
india TransPerfect Full timeOVERVIEWThe 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...
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TransPerfect | Regulatory Publisher I
23 hours ago
india TransPerfect Full timeOVERVIEW The 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...
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Regulatory Publishing Specialist
2 days ago
India TransPerfect Full timeCompany 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.
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Regulatory Publishing Team Manager
2 days ago
India TransPerfect Full timeOverviewAs 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.
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TransPerfect | Senior Regulatory Publisher
2 days ago
india TransPerfect Full timeDescription: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...
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TransPerfect | Senior Regulatory Publisher
23 hours ago
india TransPerfect Full timeDescription: 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 monthly Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable...
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TransPerfect | Team Lead, Regulatory Publisher
23 hours ago
india TransPerfect Full timeDescription: 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 monthly Oversee the task completed by a Junior Regulatory Publisher such as Publish Clinical Study Reports, IND documents, NDA documents, and other...
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india TransPerfect Full timeDescription: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...
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Regulatory Analyst
4 weeks ago
india Evoke HR Solutions Pvt. Ltd. Full timeResponsibilities -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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Regulatory Analyst
4 weeks ago
india Evoke HR Solutions Pvt. Ltd. Full timeResponsibilities-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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Am - Regulatory Reporting
7 months ago
India Sumitomo Mitsui Banking Corporation (SMBC) Full timeRegulatory reporting - Submission of Regulatory Reports, daily, fortnightly, monthly, quarterly, semiannually and annually - Providing inputs to statutory/concurrent auditors on all regulatory reporting - Responsible for Nostro reconciliations and other internal accounts tracking for Ops - Doing independent control checks for health check of various...
