The Global Regulatory Affairs group islooking for an associate to lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes.
This exciting opportunity will enable you to utilize your project management and communication skills to advance the submission process for new molecules. You will also partner with CMC Scientists to help build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission related Ministry of Health responses or company affiliate questions. You will work within regulations to expedite the registration and lifecycle maintenance of products.This is accomplished by a strong working understanding of internal procedures, guidances and regulatory precedence. You will triage and lead the communications between our Affiliates, CMC Scientists, and Specialists. You will be the point person for communication regarding submission tracking requirements to both GRA-CMC Scientists and internal customers.
Regulatory & Drug Development Expertise