• Lead strategic engagement with major partners across EMEA • Develop and execute regional sales programs with the Partner Ecosystem Success organization • Support local sales team in royalty accuracy and timing • Collaborate with the CCSP team to identify compliance issues • Serve as subject matter expert on Red Hat's subscription model • Develop strategic compliance campaigns with EcoSystem partners

Position: CUI Compliance Officer Location: Remote; with travel and onsite as needed Job Type: Full-time Reports To: Senior Facility Security Officer Position Summary: We are seeking a highly motivated and knowledgeable CUI (Controlled Unclassified Information) Compliance Officer to establish and lead our CUI compliance program. The ideal candidate will be responsible for developing, implementing, and maintaining comprehensive CUI policies and procedures, ensuring compliance with all relevant regulations, and fostering a culture of information security throughout the organization. Key Responsibilities: - Establish CUI Program - Develop and implement a comprehensive CUI compliance program. - Create and lead a dedicated full-time CUI compliance team. - Policy and Procedure Development - Develop, document, and maintain CUI policies and procedures. - Create clear guidelines and checklists for employees. - CUI Identification Process - Develop and implement clear steps for identifying CUI across the organization. - Train staff on CUI identification and handling. - New Program Initiatives - Initiate kickoff meetings for new programs to ensure CUI considerations are integrated from the start. - Support and Education - Develop and "maintain office" hours for employee questions and consultations. - Implement and manage continuous education programs on CUI compliance. - Technical Expertise - Read and interpret technical drawings and specifications to identify CUI. - Understand technical documentation and its CUI implications. - Auditing and Verification - Conduct regular audits of documents and processes for proper CUI handling. - Verify the correct application of CUI markings and protections. - Supply Chain Integration - Work closely with the supply chain team to ensure CUI protection throughout the procurement and delivery process. - Develop protocols for sharing CUI with suppliers and partners. - Compliance and Reporting - Ensure compliance with all relevant CUI regulations and standards. - Establish and manage reporting mechanisms for CUI-related issues. - Continuous Improvement - Regularly review and update CUI processes and procedures. - Stay informed about changes in CUI regulations and best practices. Qualifications: - Minimum of 5 years of experience in compliance, or a related role. - In-depth knowledge of CUI regulations, NIST SP 800-171, and related standards. - Experience developing and implementing compliance programs. - Strong analytical, organizational, and communication skills. - Ability to read and interpret technical documents and drawings. - Experience with auditing, training, and process improvement. - Experience working with government contracts.

• CMC authoring for pharmaceutical products in medical imaging • Author the CMC part of dossiers and manage worldwide submissions • Delivery of regulatory submissions and prepare responses to health authority questions

• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards • Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.