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About the Role
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.
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