Associate Director, Regulatory Project Manager

Main Responsibilities & Accountabilities

• Lead end-to-end project management of regulatory initiatives and improvement projects (initiation through closure) within budget, scope, and timelines.
• Develop, execute, and monitor project plans, risk logs, communication strategies, and status reporting.
• Oversee regulatory submissions per CSL’s Global Submission Management Process.
• Lead submission team meetings, content planning, tracking in RIMS, and ensure on-time, compliant submissions.
• Liaise with global, regional, and local teams for successful execution.
• Manage improvement projects portfolio in alignment with GRA strategy and executive priorities.
• Support quarterly reporting to Portfolio Committee and implement process efficiencies.
• Contribute to governance, best practices, and standardization across regulatory operations.

Qualifications & Experience

• 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.

Pay

The expected base salary range for this position at hiring is $170,000-210,000. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.