Lead Regulatory Publisher
Creative Solutions Services, LLC
Responsibilities: Lead and manage publishing activities for IND, NDA, ANDA, Amendments, Supplements, Responses, Annual Reports, Safety Reports, and Promotional Submissions. Oversee submission-level and document-level publishing including metadata, hyperlinking, bookmarking, TOCs, and lifecycle management. Perform and oversee quality control checks to ensure error-free regulatory submissions. Manage workload allocation, tracking, and timely delivery across teams. Support and mentor team members; conduct training sessions on publishing standards and processes. Handle client communication, status updates, and submission readiness reviews. Manage post-publishing activities including archiving and authority acknowledgements. Contribute to process improvements, automation, and business growth initiatives. Requirements: Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline. Strong expertise in eCTD/NeeS publishing for US market. Strong expertise knowledge of the Archival process. Hands-on experience with publishing tools such as DocuBridge, EXTEDO eCTD Manager, ISI Toolbox, Adobe Acrobat, and validation tools (Lorenz/eValidator). In-depth knowledge of ICH and regional regulatory submission guidelines. Experience in handling validation errors and troubleshooting technical issues. Strong stakeholder management, communication, and leadership skills. Ability to work in fast-paced, changing regulatory environments. Minimum 5 - 10 years' experience for handling submission and Archival. #J-18808-Ljbffr Creative Solutions Services, LLC
Vacancy posted 3 days ago
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