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CSL is seeking a Senior Manager, GRA CMC - Combination Product and Stand Alone Medical Device Specialist to lead global CMC regulatory strategy for drug device combination products and medical devices. In this role, you will design and execute CMC regulatory plans, author and review high quality submissions, and ensure alignment with global requirements for combination products and devices. Partnering with R D, quality, manufacturing, and clinical teams, you will guide integration of device and drug requirements, manage change control, and interact with health authorities worldwide. You will monitor regulatory trends, shape internal best practices, and mentor junior staff while contributing to CSL's mission of delivering innovative, life saving therapies in a collaborative, science driven environment. Responsibilities Lead global regulatory CMC strategy for combination products and standalone medical devices across development and lifecycle stages Prepare, review, and submit high quality regulatory documents for FDA, EMA, and other health authorities Ensure compliance with global combination product and medical device regulations, standards, and guidance (e.g., 21 CFR Part 4, ISO 13485) Provide regulatory CMC expertise to cross functional teams in R D, quality, manufacturing, and clinical development Assess regulatory impact of product and process changes and drive CMC change control strategy Interface with global health authorities, manage inquiries, and support regulatory negotiations and meetings Guide the integration of device and drug requirements in product development, risk management, and design control Monitor regulatory trends and evolving requirements for drug device combinations and medical devices Develop and maintain internal procedures, best practices, and templates for GRA CMC submissions Coach and mentor junior regulatory professionals and contribute to talent development within the GRA organization Required Skills Global regulatory CMC strategy Combination product regulations (21 CFR Part 4) Medical device regulations (EU

MDR, FDA

device requirements) CMC dossier authoring (IND/IMPD/BLA/MAA modules) Design control and risk management for devices (ISO 13485, ISO 14971) Change control and lifecycle management Health authority interaction and negotiation Technical writing for regulatory submissions Cross functional leadership and matrix collaboration Regulatory intelligence and policy interpretation