• Lead end-to-end CTA project management across multiple studies and countries • Plan, track, and deliver submissions aligned with timelines and regulatory requirements • Manage risks, dependencies, and complexities in global regulatory environments • Apply knowledge of EU CTR and ROW CTA requirements • Manage core clinical and regulatory documentation • Collaborate with cross-functional global teams • Build and maintain stakeholder relationships and resolve conflicts • Monitor KPIs related to timelines and deliverable quality • Identify risks and lead quality investigations as needed

• Lead on internal contract assurance inspections of Catch22 Employability & Skills services and to provide RAG ratings, reports and improvement plans to senior management. • This will include desk-based auditing and when required on-site audit visits at our locations across the country. • Lead on audit inspections of services ensuring that Catch22 are well prepared before and during commissioner assurance visits. • Supporting the Operations Managers to ensure compliance and auditing of staff by completing monthly PAAs and supporting the preparation and completion of Brilliant Basics audits. • Provide advice and guidance to managers and their local operational teams on these requirements and expectations to ensure complete compliance. • Provide line management to the Hub admin and ensure resource is allocated to ensure maximum efficiency of the overall compliance function. • Leading on the training and support for the division’s Admin assistants, supporting them with all their key compliance tasks, ensuring they complete the exceptions reports to help them achieve the best possible PAA scores. • Leading on training new staff on the expectations of outcome evidencing and providing guidance to the division’s Admin assistants when they are validating outcomes. • Leading on the collation of impact evidence across all services so that they can be reported quarterly. • Leading on the collation of satisfaction surveys across all programmes so that they can be reported quarterly. • Support the Operational Governance team to prepare for, and manage Matrix Standard inspections and support with any future accreditation requirements. • Assist with projects that will support the wider Catch22 organisation to achieve relevant ISO standards, Merlin, and any other recognised standards of safe, effective, high-quality operational delivery and business management. • Be responsible for compliance against the reporting calendar for the year, ensuring that services are clear on expectations and able to report with ease and on time. • Produce and develop reports on a planned basis and further interim reports as required across all services. • Work with the Data Manager to analyse data to identify and report on themes and trends for the hub to support service delivery and development. • Following processes to ensure all paperwork and performance is tracked and submitted efficiently and accurately. • Supporting staff with loading all contractual paperwork onto in-house data system when necessary. • Perform, organise, and streamline operational tasks, systems and processes to reduce the potential for errors.

• provide regulatory submission publishing services in an efficient and timely manner • key point of contact for all customers of the Regulatory Operations group • uphold “right first time” submission quality and timeliness • liaison with Regulatory Affairs and local affiliates for support • work with counterparts in other regions to facilitate global worksharing • provide best practice guidance within Submission Publishing and Document Management • provide guidance to junior staff members • support projects related to improving publishing tools, standards, and processes • monitor agency guidance & changing regulations in assigned region

• Support day-to-day U.S. import compliance activities in accordance with CBP and applicable PGA requirements • Review and approval of import documentation, HTS classifications, valuation, country of origin, and end-use documentation • Review, audit, and maintain import documentation, including commercial invoices, packing lists, customs entry records, and FDA-related import documentation • Coordinate and communicate with customs brokers, freight forwarders, carriers, and internal stakeholders to ensure timely customs clearance and delivery • Monitor international shipments and proactively resolve customs clearance or transportation issues • Assist with HTS classification and country-of-origin determinations by coordinating with internal stakeholders and external trade compliance resources as needed • Support import audit readiness and compliance reporting activities • Ensure compliance with FDA, USDA/APHIS, Fish & Wildlife Service, and other PGA import requirements • Track logistics and import compliance metrics, shipment status, transportation performance, and broker KPIs • Partner with Supply Chain, Procurement, Finance, Quality, Regulatory, and external logistics providers to improve operational efficiency • Support and lead process improvement initiatives related to trade compliance and logistics operations • Support commercial launch activities involving FTZ operations, FDA import coordination, and temperature-controlled international shipments.