Regulatory Electronic/Paper Submission Publisher

Publish paper and electronic hybrid submissions in the BLA and CTD format.
Must be able to build a submission without the use of a publishing tool.
Must have strong knowledge of Adobe Acrobat and its functions.
Knowledge of ISI Toolbox is preferred but not required and knowledge of ISI eCTDXPress is a plus.
Conduct quality reviews for various regulatory submissions formatting.
Learn and comply with company and department SOPs as well as guidances, and regulations from Health Authorities

Must have 3-5 years of pharmaceutical industry experience and up to 2 years regulatory experience