Associate Director, Regulatory Liaison

Regulatory Liaison

The Regulatory Liaison role is a broad role encompassing all aspects of regulatory strategy to support countries in the region, including clinical, CMC and risk management requirements, and oversight of strategic regional labelling issues.

Responsibilities

• 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 Auth...