Job Information
Amneal Pharmaceuticals Regulatory Affairs Specialty Associate II - NJ in Piscataway, New Jersey
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