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 position is based in Waltham, MA; King of Prussia, PA; Glattbrugg, Switzerland; or Maidenhead, UK. This is a hybrid role, with onsite work three days a week. Responsibilities Lead end‑to‑end project management of regulatory initiatives and improvement projects 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. Qualifications 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. The expected base salary range for this position at hiring is $170,000-210,000. Individual base salary will be determined by qualifications, skill level, experience, competencies, and other relevant factors. In addition to base salary, total compensation may include incentive compensation and equity. Benefits CSL offers a comprehensive benefits package, including health insurance, retirement plans, paid time off, and wellness programs. Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please refer to our accessibility statement. #J-18808-Ljbffr BioSpace