KH
Lead – Regulatory Publisher
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Staff / Principal
5 months ago
- Adobe Acrobat
- ICH
5 months ago
Not enough detail in this posting to match
- 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 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.
Lead – Regulatory Publisher · Katalyst Healthcares & Life Sciences