Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field
Expertise in eCTD/NeeS publishing for the US market
Strong knowledge of the archival process
Experience with publishing tools like DocuBridge and Adobe Acrobat
In-depth understanding of ICH and regional submission guidelines
Proficient in handling validation errors and troubleshooting
Strong communication and leadership skills
5-10 years of experience in submission and archival management
Responsibilities
Lead and manage all publishing activities related to regulatory submissions
Oversee both submission-level and document-level publishing efforts
Perform quality control checks to ensure compliance and accuracy
Manage allocation of workload and ensure timely delivery
Support and mentor team members, providing training on standards
Communicate with clients regarding submission statuses and readiness
Manage post-publishing processes including archiving and acknowledgements
Drive process improvements and automation initiatives
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.
