CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, the team is committed to developing therapies that make a meaningful difference worldwide. The position is based in Waltham MA, King of Prussia PA, Glattbrugg Switzerland or Maidenhead UK Office, and is hybrid with onsite work three days a week.
Tasks
- Lead end-to-end project management of regulatory initiatives and improvement projects from 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.
- Lead 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.
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.
Benefits
- The expected base salary range for this position at hiring is $170,000-210,000.
- Total compensation may include incentive compensation and equity.
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Über uns
Das Team
The team thrives in dynamic biotech ecosystems with a focus on collaboration and cross-functional leadership, including Regulatory, Clinical, Manufacturing, POE (GPM), and external partners.