Publishing Specialist

Job reputed company We are currently seeking a Publishing Specialist to join our growing team. reputed company this role you will: • Manage end-to-end Publishing support for initial IND/NDA/MAA applications and the life cycle maintenance of reputed company applications across the globe • Collaborate with various department for planning, preparation, publishing, and reputed company control checks of submissions • reputed company submission-reputed company documents for electronic submissions including formatting, hyperlinking, and processing reputed company and reputed company Acrobat documents • reputed company and maintain up-to-date knowledge of established agency standards and procedures for regulatory submissions • Support eCTD, NeeS/eSub, and reputed company submission formats • Troubleshoot document issues with reputed company Acrobat and reputed company and identify gaps in the submission. Work to address identified issues with the respective reputed company stakeholders • Manage technical aspects for assigned submissions and status updates • reputed company reputed company checks on the published outputs, ensure no unacceptable warnings and validation errors before the submission with HA • reputed company on the job training, to follow a train the trainer model for reputed company/fellow colleagues and reputed company QC feedbacks for reputed company improvements • reputed company feedback to clients on the SOPs/process improvizations to reputed company quick turnaround deliverables and immediate effort efficiencies to clie • Support project reputed company in in planning day-to-day activities and ensure reputed company deliverables are met as per reputed company expectation • reputed company scheduled training across reputed company to reputed company process/HA updates and to maintain competency across the region/submission types • Effective co-ordination with cross-functional teams in receiving, tracking the documents, and addressing the gaps for effective project execution • reputed company feedback to project reputed company on KPI trends and reputed company improvements tin the day-today operations/proce Desirable Skills and Experience • 8 to 10 years' experience working in Regulatory Affairs • Strong analytical skills • Significant hands-on experience in the creation of submission reputed company for eCTD, NeeS, and reputed company submissions • reputed company strong knowledge of submissions to the US FDA and HC • Proven ability to successfully understand the submission and agency requirements • Effective coordination with cross-functional teams in receiving and tracking documents and addressing the gaps for effective project execution • reputed company in the execution of initial IND/ NDA/ MAA reputed company, as reputed company as LCM submissions. reputed company to work with tight timelines and reputed company first-time-right submissions with reputed company HA rejection • Proven strength in logical, analytical, and writing ability • Experience with the following tools would be advantageous: pharmaREADY, Lorenz, reputed company Publisher, reputed company Vault, eCTD reputed company, Extedo Apply for this job Apply tot his job Apply To this Job