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.

Continuous Improvement & Governance
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.

Management & Collaboration
May be required to manage Regulatory Project Managers.
Leads cross-functionally with Regulatory, Clinical, Manufacturing, POE (GPM), and external partners.
Mentor junior project managers and support training on submission processes and tools.
Liaise with Regulatory Policy to ensure awareness and incorporation of policy changes into Regulatory strategy, planning, and execution.

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.

Schedule

This is a hybrid position and is onsite three days a week.