Associate Director, Regulatory Liaison

The Regulatory Liaison role is a broad role encompassing all aspects of regulatory strategy to support countries in region, including clinical, CMC and risk management requirements, and oversight of strategic regional labelling issues. In this role, the Regulatory Liaison has responsibilities including: Serves as single POC for specific products for country and HQ. Provides regionally focused strategic input to product development across region and across portfolio. Contributes to region specific aspects of a development strategy. Leads identification of regional specific elements of submissions. Owns and leads the overall regional product regulatory strategy, including the corporation and maintenance of regulatory requirements for health authority registration approval. Monitors and communicates key strategic issues related to program progress and issues to/from countries and HQ. Manage the execution of Health Authority (HA) Response to Questions (RTQ) for both product marketing and a...