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Biotech
Manage accurate and compliant Japan payroll operations, including employee inquiries, social insurance, benefits, retirement payments, PTO, attendance, overtime, vendor processing, statutory reporting, and payroll data in Workday. Coordinate with HR, Finance, Benefits, vendors, employees, and government agencies. Support audits, reporting, forecasting, payroll accounting, process improvements, and system or vendor transitions.
Biotech
Leads global tax reporting, accounting, forecasting, provisioning, governance, and transparency activities. Owns the OneSource tax provisioning platform, drives automation and process improvements, and ensures compliance with Pillar Two and Country-by-Country Reporting requirements. Partners with global Finance and Tax teams, oversees tax disclosures and Board reporting, supports strategic tax initiatives, and provides leadership on emerging international tax developments.
Biotech
Develop global regulatory CMC strategies for biologics and plasma-derived therapies. Lead digital innovation, regulatory intelligence, submission management, outsourcing governance, KPI monitoring, policy development, SOP implementation, inspection support, and due diligence. Coordinate cross-functional and external stakeholders across global geographies, interpret FDA, EMA, PMDA, and NMPA regulations, advise senior leaders, and support compliant product development, registration, and lifecycle management.
Biotech
Leads regulatory affairs operations and strategy across Australia and New Zealand for CSL. Oversees product registrations, lifecycle management, regulatory submissions, labeling, promotional review, compliance, audit readiness, and CAPA completion. Acts as the primary interface with health authorities, government bodies, industry associations, and commercial teams while guiding regulatory teams and managing complex cross-functional timelines.
Biotech
Lead global vaccines safety science activities including pharmacovigilance governance, regulatory compliance, signal detection, safety data analysis, inspection readiness, PSMF maintenance, process optimization, and technical translation of business requirements into reporting and visualization solutions. Manage teams, contribute to post-marketing and study safety reporting, and support regulatory submissions and audits.
Biotech
Lead global labelling strategy and operations for Seqirus' vaccine portfolio, manage and coach a global labelling team, own end-to-end labelling review and approval, ensure regulatory compliance and timely safety updates, support annual strain updates, represent company in regulatory forums and audits, and collaborate cross-functionally to deliver timely labelling.
Biotech
Leads Japan-focused regulatory CMC strategy for biopharmaceutical products, including regulatory filings, health authority interactions with PMDA and MHLW, submission management, lifecycle activities, compliance, risk assessment, and cross-functional collaboration. Provides strategic guidance, mentors colleagues, maintains regulatory records, and supports product development, registration, commercialization, and continuous process improvement.
Biotech
Serve as CSL's senior representative in the regional biotech ecosystem to source and evaluate external innovation, build executive partnerships, support regional BD/licensing transactions end-to-end, provide market intelligence, and represent CSL at industry and government forums to shape strategic pipeline opportunities.
