Associate Director, Regulatory Project Manager

Das ist der Job

ppCSL's RD organization is accelerating innovation to deliver greater impact for patients.

Darum lohnt es sich

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. /p pCould you be our next Associate Director, Regulatory Project Manager?

This role oversees submission coordination, and cross-functional collaboration to meet global health authority requirements and drive operational excellence. /p h3Main Responsibilities Accountabilities /h3 h3Regulatory Project Leadership /h3 ul liLead end-to-end project management of regulatory initiatives and improvement projects (initiation through closure) within budget, scope, and timelines. /li liDevelop, execute, and monitor project plans, risk logs, communication strategies, and status reporting. /li /ul h3Submission Coordination /h3 ul liOversee regulatory submissions per CSL’s Global Submission Management Process. /li liLead submission team meetings, content planning, tracking in RIMS, and ensure on-time, compliant submissions. /li liLiaise with global, regional, and local teams for successful execution /li /ul h3Continuous Improvement Governance /h3 ul liManage improvement projects portfolio in alignment with GRA strategy and executive priorities. /li liSupport quarterly reporting to Portfolio Committee and implement process efficiencies. /li liContribute to governance, best practices, and standardization across regulatory operations. /li /ul h3Management Collaboration /h3 ul liMay be required to manage Regulatory Project Managers /li liLeads cross-functionally with Regulatory, Clinical, Manufacturing, POE (GPM) and external partners. /li liMentor junior project managers and support training on submission processes and tools. /li liLiaise with Regulatory Policy to ensure awareness and incorporation of policy changes into Regulatory strategy, planning, and execution /li /ul h3Qualifications Experience /h3 ul liBachelor’s degree in Life Sciences or Business required; advanced degree (MSc, PhD, MBA) and PMP certification preferred. /li li7+ years of experience in pharma/biotech industry with a focus on biologics and regulatory affairs. /li li7+ years’ experience managing global, cross-functional projects in a matrix environment. /li liStrong knowledge of global regulatory submission processes, drug development lifecycle, and project governance. /li liDemonstrated success in delivering complex projects on time and within scope. /li /ul pThe expected base salary range for this position at hiring is $170,000-210,000.

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. /p pYou 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.

Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors.

In addition to base salary, total compensation for this role may also include incentive compensation and equity. /p /p