Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.
Expertise in eCTD/NeeS publishing specifically for the US market.
Knowledge of the Archival process is essential.
Hands-on experience with publishing tools like DocuBridge, EXTEDO, ISI Toolbox, and Adobe Acrobat.
In-depth understanding of ICH and regional regulatory submission guidelines.
Experience with handling validation errors and troubleshooting.
Strong stakeholder management and leadership skills developed over minimum 5-10 years in the field.
Responsibilities
Lead and manage all publishing activities related to regulatory submissions.
Oversee document-level publishing tasks including metadata and lifecycle management.
Ensure quality control checks for error-free submissions.
Track workload allocation and manage team delivery timelines.
Support and mentor team members, conducting training on publishing standards.
Communicate with clients regarding status updates and submission readiness.
Manage post-publishing tasks like archiving and acknowledgements.
Drive process improvements and contribute to business growth initiatives.
Benefits
Comprehensive health and wellness benefits.
Support for continuous learning and professional development.
Flexible working arrangements to promote work-life balance.
Opportunities for career advancement within the organization.
Full Job Description
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.
bility to work in fast-paced, changing regulatory environments.
Minimum 5 - 10 years' experience for handling submission and Archival.
