We are currently seeking a Publishing Specialist to join our growing team. Within this role you will:

• Manage end-to-end Publishing support for initial IND/NDA/MAA applications and the life cycle maintenance of all applications across the globe
• Collaborate with various department for planning, preparation, publishing, and quality control checks of submissions
• Develop submission-ready documents for electronic submissions including formatting, hyperlinking, and processing MS Word and Adobe Acrobat documents
• Develop and maintain up-to-date knowledge of established agency standards and procedures for regulatory submissions
• Support eCTD, NeeS/eSub, and Paper submission formats
• Troubleshoot document issues with Adobe Acrobat and MS Word and identify gaps in the submission. Work to address identified issues with the respective client stakeholders
• Manage technical aspects for assigned submissions and status updates
• Perform quality checks on the published outputs, ensure no unacceptable warnings and validation errors before the submission with HA
• Perform on the job training, to follow a train the trainer model for beginners/fellow colleagues and provide QC feedbacks for continuous improvements
• Provide feedback to clients on the SOPs/process improvizations to achieve quick turnaround deliverables and immediate effort efficiencies to clie
• Support project lead in in planning day-to-day activities and ensure timely deliverables are met as per client expectation
• Provide scheduled training across the team to share 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
• Provide feedback to project lead on KPI trends and continuous improvements tin the day-today operations/proce

• 8 to 10 years’ experience working in Regulatory Affairs
• Strong analytical skills
• Significant hands-on experience in the creation of submission output for eCTD, NeeS, and Paper submissions
• Very 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
• Experienced in the execution of initial IND/ NDA/ MAA projects, as well as LCM submissions. Able to work with tight timelines and achieve first-time-right submissions with zero HA rejection
• Proven strength in logical, analytical, and writing ability
• Experience with the following tools would be advantageous: pharmaREADY^®, Lorenz, Insight Publisher, Veeva Vault, eCTD Express, Extedo