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
Hands-on experience with publishing tools like DocuBridge and Adobe Acrobat
In-depth understanding of ICH and regional regulatory submission guidelines
Experience in troubleshooting validation errors and technical issues
Strong communication and leadership skills
Ability to adapt in fast-paced regulatory environments
5-10 years of experience in handling submissions and archival
Responsibilities
Lead publishing activities for various regulatory documents including IND and NDA
Oversee document publishing aspects such as metadata and hyperlinking
Perform quality control checks for regulatory submissions
Manage workload allocation and ensure timely delivery
Support and mentor team members through training on publishing standards
Handle client communications and submission readiness reviews
Manage post-publishing activities like archiving and acknowledgements
Contribute to process improvements and automation initiatives
Benefits
Professional development opportunities
Collaborative and supportive team environment
Flexible working arrangements
Access to advanced publishing tools and resources
Opportunities for mentorship and leadership training
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.
