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