Manager, Regulatory Clinical Trial Authorization (CTA)

Translate global CTA strategies into study‑level regulatory approaches, ensuring alignment with development priorities and applicable regulatory requirements delivered via outsourced partners. Provide CTA guidance and strategic direction to external service providers, Study Teams, and cross‑functional stakeholders within the approved framework. Support early risk‑based CTA planning for critical or complex studies, including country approach, sequencing considerations, and identification of regulatory sensitivities. Ensure consistent application of regulatory intelligence and evolving requirements across assigned studies. Act as the internal CSL CTA interface for assigned clinical studies, providing cross‑functional coordination and governance oversight within the outsourced delivery model. Act as the primary oversight contact for external partners performing CTA activities. Execute defined risk‑based oversight activities in line with established governance, oversight plans and ways of working documents. Monitor vendor performance against agreed KPIs, timelines, and quality expectations and contribute to joint improvement initiatives with partners. Ensure outsourced CTA activities are conducted in compliance with GCP requirements and internal procedures. Support preparation for Health Authority inspections, audits, including participation as the internal reg CTA representative. Proactively escalate compliance risks or deviations and propose appropriate mitigation actions. Proactively ensure adherence to CTA processes and working practices supporting the outsourced delivery model. Continuously identify process inefficiencies, quality issues, or recurring risks impacting CTA delivery or oversight and drive improvement actions. Lead and support implementation of approved process changes, tools, and templates in collaboration with relevant stakeholders. Actively contribute to CTA metrics, dashboards, and reporting to strengthen oversight and inform decision‑making.

CSL 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. 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.

• A degree (BSc/MSc) or equivalent in life science, pharmacy or other health/medical related field

• A minimum of 5 years’ experience in managing Clinical Trial Authorizations

• Strong experience with CTA requirements and processes, including EU CTR.

• Experience working with or overseeing external vendors/CROs.

• Extensive and comprehensive knowledge of ICH guidelines/GCP and current medical/scientific/regulatory knowledge incl. inspection expectation

• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies

• Strong regulatory judgment within defined strategic frameworks

• Structured, risk‑based oversight mindset

• Ability to manage complexity and priorities in a matrix environment

• Clear communication and issue escalation skills

• Quality‑ and compliance‑focused approach

• Customer service focus

• Excellent written and oral communication skills in English

• Maintains computer literacy in appropriate software