• Responsible for developing and implementing UK regulatory strategies for product(s). • Lead the UK RA team to manage regulatory aspects of compounds. • Collaborate with key internal stakeholders on UK MAA strategy. • Manage the content and prepare regulatory (UK MAA) dossiers. • Oversee communications, submissions, and approvals from regulatory agencies. • Act as the RA liaison within the UK Leadership team and provide input into UK business strategy. • Anticipate and mitigate regulatory risks while maintaining knowledge of regulatory intelligence. • Mentoring junior team members and representing BeOne at UK industrial meetings.

Role Description Remote Recruitment is hiring a Compliance Officer to ensure a UK-based business operates within regulatory and legal frameworks. Working fully remotely from South Africa, you'll maintain compliance programmes, conduct reviews, and advise the business on regulatory matters. - Monitor regulatory developments and assess their impact on business operations - Maintain and update compliance policies, procedures, and frameworks - Conduct internal compliance audits and risk assessments - Provide compliance training and guidance to staff across the business - Liaise with regulators and manage regulatory reporting obligations Qualifications - 4+ years of compliance experience, ideally in financial services or a regulated UK industry - Strong knowledge of UK regulatory frameworks and compliance requirements - Excellent analytical skills and attention to detail - Clear and concise written and verbal communication skills - Reliable internet and a professional home workspace Benefits - Salary: R32,000 per month - Full-time, permanent remote position - Working hours: 09:00–17:00 UK time (11:00–19:00 SAST) - Equipment provided - 20 days paid leave Company Description We welcome all applicants. Apply today to play a critical role in a UK-regulated business.

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant. • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration. • Prepare, review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Forms. • Responsible for/facilitates the translation and co-ordination of translations for documents required for submission. • Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF. • May support the clinical team performing Pre-Study Site Visits. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Will support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors. • Will support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries. • Will mentor staff on local country regulations, submissions and internal procedures, as well as on PFM SSU specific guidance and tools. • Can assume ownership of departmental process improvements / initiatives, including finalization, roll out and periodic reviews. • May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required.

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant. • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration. • Prepare, review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Forms. • Responsible for/facilitates the translation and co-ordination of translations for documents required for submission. • Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF • May support the clinical team performing Pre-Study Site Visits. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Will support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors. • Will support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries. • Will mentor staff on local country regulations, submissions and internal procedures, as well as on PFM SSU specific guidance and tools. • Can assume ownership of departmental process improvements / initiatives, including finalization, roll out and periodic reviews. • May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required. • May act up in the role of Start Up Lead to drive site start up activities to meet activation timelines on smaller or single country studies or by acting as a regional Start Up Lead on larger global studies under the direction of the global Start Up Lead. • May interact with clients during KOMs, including slide development and client presentation, as required.