Manager, Regulatory Clinical Trial Authorization (CTA)

Overview:

The Manager, Clinical Trial Authorization (CTA) 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.

Reporting 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.

The 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

Responsibilities:

CTA Strategy Implementation & Regulatory CTA Support

• 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.

Oversight of Outsourced CTA Activities

• 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.

Quality, Compliance & Inspection Readiness

• 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.

Process Adherence & Continuous Improvement

• 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.

Qualifications:

Education:

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

Experience:

• 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

Competencies

• 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

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