Responsible for the preparation of documents for publishing, compilation, and QC of regulatory submissions to Regulatory Health Authorities (e.g., FDA), including but not limited to IND, BLA/NDA, IND amendments, meeting requests and briefing books.
Knowledgeable of eCTD templates and structure of Modules (1-5)
Word formatting, PDF publishing and eCTD backbone compilation of regulatory submissions.
Assures completeness and quality of submissions from the operations perspective.
Identifies issues, suggests and implements solutions
Proper archiving of regulatory submissions
Knowledge of current regulations, laws and guidance both US and ex-US
Responsible for interaction with team across a number of development programs.
Capable of developing and adhering to time lines
Interface with Project Managers, Regulatory Leads, and/or content authors to provide technical guidance and support in finalizing submission content
Promote and demonstrates collegiality with all firm members.
Participates in the training and development programs
Education and Skills
Extensive knowledge of IND/BLA/eCTD and other electronic requirements and guidelines