Associate Director, Regulatory Affairs, Marketed Products Portfolio

Job description

Job Description Summary This role reports to the Head of Regulatory Affairs, USCAN for GE HealthCare’s Pharmaceutical Diagnostics (PDx). This role drives regulatory strategy and execution for new product development and lifecycle management of marketed products. The incumbent will serve as the face of Regulatory Affairs on cross-functional teams, ensuring timely submissions, approvals, and compliance across global markets. Job Description: Key Responsibilities: Regulatory Strategy & Execution Develop and execute on regulatory strategies to enable timely product approvals and lifecycle management in key markets including but not limited to US and Canada. Provide strategic regulatory advice to optimize product development (new and marketed products) and speed to market e.g. via Fast Track and Breakthrough Designations. Assess changes to marketed products and lead post-approval submissions in key markets, including but not limited to US and Canada. Coordinate and prepare responses to submissions related questions. Review and contribute to submissions for products in development and marketed products, including INDs/CTAs, Clinical Study Protocols, CBEs, PAS and other documents of regul...