Manager, regulatory clinical trial authorization (cta)

POverview: /ppThe bManager, Clinical Trial Authorization (CTA) /b is responsible for ensuring that CTA activities for assigned clinical studies are planned, governed, and overseen in line with CSL regulatory expectations, quality standards, and development timelines. /ppReporting to the Director, Global Regulatory CTA, the role translates global CTA direction into clear, study‑specific regulatory approaches, provides guidance to Study Teams and partners, and acts as the first line CTA point of contact across functions. The position ensures that CTA activities delivered by external partners are appropriately overseen, risks are identified early and managed proactively. /ppThe role maintains a strong focus on quality, inspection readiness, and continuous improvement by monitoring performance, contributing to metrics and dashboards, driving pragmatic process enhancements, and representing CTA internally during audits and inspections, as required. This role reports to the Director, Global Regulator CTA /ppbResponsibilities: /b /ppbCTA Strategy Implementation Regulatory CTA Support /b /pliTranslate global CTA strategies into study‑level regulatory approaches, ensuring alignment with development priorities and applicable regulatory requirements delivered via outsourced partners. /liliProvide CTA guidance and strategic direction to external service providers, Study Teams, and cross‑functional stakeholders within the approved framework. /liliSupport early risk‑based CTA planning for critical or complex studies, including country approach, sequencing considerations, and identification of regulatory sensitivities. /liliEnsure consistent application of regulatory intelligence and evolving requirements across assigned studies. /liliAct as the internal CSL CTA interface for assigned clinical studies, providing cross‑functional coordination and governance oversight within the outsourced delivery model. /lipbOversight of Outsourced CTA Activities /b /pliAct as the primary oversight contact for external partners performing CTA activities. /liliExecute defined risk‑based oversight activities in line with established governance, oversight plans and ways of working documents. /liliMonitor vendor performance against agreed KPIs, timelines, and quality expectations and contribute to joint improvement initiatives with partners. /lipbQuality, Compliance Inspection Readiness /b /pliEnsure outsourced CTA activities are conducted in compliance with GCP requirements and internal procedures. /liliSupport preparation for Health Authority inspections, audits, including participation as the internal reg CTA representative. /liliProactively escalate compliance risks or deviations and propose appropriate mitigation actions. /lipbProcess Adherence Continuous Improvement /b /pliProactively ensure adherence to CTA processes and working practices supporting the outsourced delivery model. /liliContinuously identify process inefficiencies, quality issues, or recurring risks impacting CTA delivery or oversight and drive improvement actions. /liliLead and support implementation of approved process changes, tools, and templates in collaboration with relevant stakeholders. /liliActively contribute to CTA metrics, dashboards, and reporting to strengthen oversight and inform decision‑making. /lipbQualifications: /b /ppbEducation: /b /pliA degree (BSc/MSc) or equivalent in life science, pharmacy or other health/medical related field /lipbExperience: /b /pliA minimum of 5 years’ experience in managing Clinical Trial Authorizations /liliStrong experience with CTA requirements and processes, including EU CTR. /liliExperience working with or overseeing external vendors/CROs. /liliExtensive and comprehensive knowledge of ICH guidelines/GCP and current medical/scientific/regulatory knowledge incl. inspection expectation /lipbCompetencies /b /pliDemonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies /liliStrong regulatory judgment within defined strategic frameworks /liliStructured, risk‑based oversight mindset /liliAbility to manage complexity and priorities in a matrix environment /liliClear communication and issue escalation skills /liliQuality‑ and compliance‑focused approach /liliCustomer service focus /liliExcellent written and oral communication skills in English /liliMaintains computer literacy in appropriate software /lippbbAbout CSL Behring /b /b /p /ppCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. /ppbr/CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. /ppTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at . /ppbOur Benefits /b /p