Duties may include:

• Manage multiple, large, and complex global regulatory submission projects in eCTD and non-eCTD [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, compliance submissions, etc.] efficiently, accurately and simultaneously.
• Key contributor in submission management activities related to acquisitions, partnerships, and divestitures, key supporter of regulatory agency inspections, and other miscellaneous regulatory operational activities.
• Provides expert guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, and eCTD document lifecycle management and submission compilation workflows.
• Lead, coach, and mentor peers and colleagues.
• Develops and authors training materials and leads efforts to implement training to ensure optimal use of templates, processes, and tools critical related to regulatory submission activities.
• Expert advisor in evaluation, selection, and implementation of technologies and processes related to submission planning, publishing, assembly, and archiving (as needed).
• Submission Management Representative on key internal initiatives, Health Authority meetings, and various industry forums/conferences, as required.
• Strong ability to troubleshoot and assess technical/quality issues relating to compilation, validation, and dispatch of global submission outputs with accuracy.