Responsibilities: Support the Senior Director in developing and executing regional regulatory strategies for QOL... to the Senior Director and Associate Director. Contribute to managing regulatory risks and opportunities related to QOL...
, submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER..., FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions. Provide regulatory guidance...
The Senior Manager, Product & Pipeline Communications (PPC) plays a pivotal role in strengthening and protecting the..., Medical Affairs, Legal and Regulatory – for collaboration on disease/brand awareness, launch preparedness and post-market...