Lead � Regulatory Publisher

Katalyst CRO; Austin (TX); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO in Austin, TX, seeks a senior Regulatory Publishing Lead to manage IND, NDA, ANDA submissions and related reports. You will oversee end-to-end publishing, metadata, hyperlinks, bookmarks, and lifecycle management.

The role requires 5–10 years in regulatory submissions, expert knowledge of eCTD/NeeS for the US market, and strong stakeholder leadership. You will mentor teams and drive process improvements in a fast-moving environment.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline.
• Strong expertise in eCTD/NeeS publishing for US market.
• In-depth knowledge of Archival process.
• Experience with DocuBridge, EXTEDO eCTD Manager, ISI Toolbox, Adobe Acrobat, and Lorenz/eValidator.
• Knowledge of ICH and regional regulatory submission guidelines.
• Experience 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 handling submissions and Archival.

Responsibilities

• Lead and manage publishing activities for IND, NDA, ANDA, Amendments, and Reports.
• Oversee submission-level and document-level publishing including metadata, bookmarking, and TOCs.
• Perform and oversee quality control checks to ensure error-free submissions.
• Manage workload allocation, tracking, and timely delivery across teams.
• Support and mentor team members; conduct training on publishing standards.
• 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.

Skills

Stakeholder management

Communication

Leadership

Mentoring

Training

Education

Bachelor's degree in Pharmacy or Life Sciences

Master's degree in Pharmacy or Life Sciences

Tools

DocuBridge

EXTEDO eCTD Manager

ISI Toolbox

Adobe Acrobat

Lorenz/eValidator

Job description

• 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.

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.