Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline.
Strong expertise in eCTD/NeeS publishing for the US market.
In-depth knowledge of ICH and regional regulatory submission guidelines.
Hands-on experience with publishing tools like DocuBridge and Adobe Acrobat.
Strong stakeholder management and leadership skills.
Minimum 5-10 years of experience in submission handling and Archival.
Responsibilities
Lead and manage publishing activities for regulatory submissions.
Oversee submission-level and document-level publishing processes.
Perform quality control checks for regulatory submissions.
Manage workload allocation and ensure timely delivery across teams.
Support and mentor team members on publishing standards.
Handle client communication and submission readiness reviews.
Contribute to process improvements and business growth initiatives.
Benefits
Opportunities for professional development and training.
Supportive work environment with mentoring.
Engagement in process improvement initiatives.
Flexibility in handling client communications and team management.
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.
