Lead Regulatory Publisher

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.