Associate Director, Regulatory Project Manager

Associate Director, Regulatory Project Manager – Hybrid position (Waltham, MA; King of Prussia, PA; Glattbrugg, Switzerland; Maidenhead, UK). Three days onsite per week. 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. Submission Coordination : 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 : Manage Regulatory Project Manager leads; cross‑functionally lead 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 incorporate policy changes into 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 focusing on biologics and regulatory affairs. 7+ years of 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. Compensation Base salary range: $170,000 - $210,000. Total compensation may include incentive compensation and equity. 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 visit #J-18808-Ljbffr