Description:

The Associate II assists with minimal guidance, the Director of Specialty Regulatory Affairs with all IND/NDA related activities.

Essential Functions:

• Compilation of regulatory submissions including INDs, NDAs, amendments and supplements and manage submission timelines.
• Mantain regulatory information system, including archiving, deliverables calendar. Track recurring regulatory activities, develop and manage submission roadmaps
• Cross functional meeting management, including creation and distribution of agenda and meeting minutes
• Routine monitoring of regulatory intelligence
• Manage clinicaltrials.gov database

Additional Responsibilities:

• Backup eCTD publishing
• Special regulatory research projects as needed