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.

• 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 Docu Bridge, 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.