Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department.
Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
Document regulatory strategies for product submissions.
Facilitate and prepare U.S. regulatory Pre-Submissi...