Lead Regulatory Publisher
Katalyst CRO, Edison, NJ, United States
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.
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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.
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