Associate Director, Regulatory Project Manager

Role Overview

• Lead end-to-end project management of regulatory initiatives and improvement projects (initiation through closure) within budget, scope, and timelines.
• Oversee regulatory submissions per CSL’s Global Submission Management Process.
• Manage improvement projects portfolio in alignment with GRA strategy and executive priorities.
• Mentor junior project managers and support training on submission processes and tools.

Requirements

• Bachelor’s degree in Life Sciences or Business required; advanced degree (MSc, PhD, MBA) and PMP certification preferred.
• 7+ years of experience in pharma/biotech industry with a focus on biologics and regulatory affairs.
• 7+ years’ experience managing global, cross-functional projects in a matrix environment.
• Strong knowledge of global regulatory submission processes, drug development lifecycle, and project governance.
• Demonstrated success in delivering complex projects on time and within scope.

Tech Stack

• PMP

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development opportunities