Associate Director, Regulatory Project Manager

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Associate Director, Regulatory Project Manager? The job is in our Waltham MA, King of Prussia PA, Glattbrugg Switzerland or Maidenhead UK Office. This is a hybrid position and is onsite three days a week.

You will lead global regulatory project planning and execution across CSL's product portfolio, ensuring timely delivery of submissions and improvement initiatives aligned with GRA strategy. This role oversees submission coordination, and cross-functional collaboration to meet global health authority requirements and drive operational excellence.

Main Responsibilities & Accountabilities:

Regulatory Project Leadership

• 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.
  

• 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
  

• 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.