Role Description Delcath is seeking for a well-rounded FDA regulatory professional with experience or familiarity with promotional and medical material review for approved prescription drugs and/or devices. The position will serve on the company’s promotional/medical material review committee for both the United States and Europe for an approved drug/device in the United States and a Class III medical device in Europe. The position will also be required to support other regulatory projects as required, including those relating to clinical trials, early-stage discovery, investigational applications, manufacturing, and quality issues. Essential Duties and Responsibilities - Review of promotional and medical material for an approved drug in the United States and a Class III medical device in Europe. - Management of US and Global regulatory activities associated with advertising and promotion for company marketed products. - Provide review of US and Global product and disease state materials/communications to support corporate goals and comply with applicable laws, regulations, and guidance. - Contribute to and advise on the development of product messages and materials across multiple functional areas, including clinical trial materials. - Provide timely regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs. - Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal. - Help lead and assist in interactions with the FDA Office of Prescription drug Promotion (OPDP), responsible for helping to maintain good working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters. - Responsible for compliance with promotional material submissions to FDA on Form 2253. - Monitors the evolving regulatory landscape and requirements, and maintain vigilance regarding FDA promotional enforcement activities to, in partnership with management, provide stakeholders with updates and impact of enforcement activities. - Ability to identify process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies. - Provide input during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising. - Support regulatory affairs department in other tasks as needed. Qualifications - A BS or MS degree in physical or life sciences required. - Must have at least 5 years drug with Regulatory Advertising and Promotion. - Must have knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with focus in advertising and promotion. - Experience with pharmaceutical products required, drug/device combination product experience a plus. - Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred. - Ability to review promotional materials and interact with FDA OPDP/APLB. - Excellent written/verbal communication skills. - Understanding of clinical trial recruitment materials and labeling regulations. - Experience working across multi-disciplinary levels, functions and regions is required. - Must be team oriented, with the ability to work well with diverse cross-functional teams. - Must possess strong analytical and process skills and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc. - Must possess strong verbal and written communication skills. - Must be willing to travel. Requirements - Ability to read and interpret documents such as technical journals, safety rules, operating and maintenance instructions, and procedure manuals. - Ability to write routine reports and correspondence. - Ability to speak effectively with employees and outside organizations. - Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. - Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs. Physical Demands - While performing the duties of this job, the employee will be required to occasionally travel to clinical trial sites. - While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. - The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. - The employee must occasionally lift and/or move up to 10 pounds. - Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Develop, implement, and maintain company-wide DOT compliance programs, policies, procedures, and standards while fostering a proactive compliance culture focused on safety, accountability, and continuous improvement. • Ensure compliance with all applicable Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT), state transportation, and related regulatory requirements. • Serve as the primary resource for DOT compliance guidance and interpretation throughout the organization. • Monitor regulatory changes and assess operational impacts, communicating requirements and recommendations to leadership. • Lead internal audits and compliance reviews to identify risks and corrective actions. • Establish and maintain compliance metrics, dashboards, and reporting for executive leadership. • Oversee preparation for and response to DOT audits, investigations, inspections, and regulatory inquiries. • Manage corrective action plans and ensure timely resolution of compliance findings. • Oversee Driver Qualification File (DQF) compliance and administration. • Ensure compliance with driver hiring, onboarding, licensing, medical certification, and qualification requirements. • Develop and deliver DOT compliance training programs for drivers, supervisors, managers, and operational leaders. • Provide coaching and support to operational leaders regarding compliance expectations and corrective actions. • Manage Motor Vehicle Record (MVR) monitoring programs and driver risk assessments. • Oversee Hours of Service (HOS) compliance, Electronic Logging Device (ELD) programs, and related recordkeeping requirements. • Lead drug and alcohol testing programs, including pre-employment, random, post-accident, reasonable suspicion, return-to-duty, and follow-up testing requirements. • Partner with Human Resources and Safety teams on compliance-related employee matters. • Ensure compliance with vehicle inspection, maintenance, and recordkeeping requirements. • Partner with Fleet and Operations leadership to establish preventive maintenance compliance standards. • Monitor vehicle registration, permitting, and licensing requirements. • Support oversized/overweight transportation compliance requirements as applicable. • Analyze compliance trends, incidents, violations, and audit findings to identify improvement opportunities. • Develop strategies to improve performance and reduce organizational risk. • Lead continuous improvement initiatives that enhance compliance effectiveness and operational efficiency. • Perform other duties as assigned.

Role Description This role is responsible for organizing, coordinating, and communicating Utilization Management (UM) business needs, including integration with internal application systems and the enterprise data warehouse. The position supports the development, implementation, and ongoing maintenance of UM data solutions, ensuring alignment with business objectives and regulatory requirements. Serving as a key liaison, this role provides subject matter expertise on UM data, promoting data integrity, accuracy, and effective information management across the organization. The position requires strong attention to detail and advanced technical aptitude to identify issues, analyze root causes, and implement effective solutions that enhance data quality and operational performance. - Coordinate and translate UM business needs into data and system requirements, ensuring alignment with enterprise applications and data warehouse structures. - Drives the development and sustainment of UM data solutions, ensuring compliance with operational and regulatory standards while owning the analysis and quality monitoring of data outputs. - Act as a subject matter expert and liaison for UM data, driving data integrity, governance, and consistency across systems. - Routinely monitors data outputs to identify data discrepancies and system issues; develop and implement solutions to improve accuracy and performance. - Participates in various projects by delivering data-driven insights that support internal and external program development, cost and utilization trend analysis, and clinical management initiatives. - Partner cross-functionally with IT, analytics, data science, and business teams to enhance data workflows and reporting capabilities. - Accountable for maintaining technical documentation related to Utilization Management (UM) reporting requirements, ensuring accuracy, completeness, and alignment with regulatory and operational standards. - Participate in User Acceptance Testing (UAT) for UM systems, validating that system changes meet defined business and technical requirements. Qualifications - Demonstrates strong communication skills, effectively and consistently engaging diverse audiences. - Excels in organizing and managing competing priorities, multitasking in fast-paced environments. - Possess great attention to details along with strong technical aptitude to recognize issues along with problem-solving skills. - Project management skills, ability to manage assigned projects with detailed project plans and methodologies. - Ability to identify operational and service problems, recommend and implement process enhancements. - Uses Excel and data analysis tools to organize, review, and summarize operational data. - Applies foundational data-structure knowledge to support quality checks and requirements gathering. - Reviews vendor data submissions and reporting logic with enough analytic fluency to ask effective follow-up questions. Requirements - 5 years of experience in an analytical business environment, with a strong focus on operations data and information management. - Advanced proficiency in PC applications, including Excel, Crystal Reports, Power BI, and various reporting and testing approaches. - Knowledge of UM-specific health plan regulations preferred. - Familiarity with business process modeling, requirements gathering, and project management methodologies. Education and Certifications - Bachelor’s degree in business administration, health care administration, information systems or related field required or additional 4 years relevant experience. Physical Demands - Sedentary work that involves significant periods of sitting, talking, hearing, and keying. - Work environment includes typical office conditions.

• Serve as the principal security advisor to CPS’s Government Security Committee (GSC) • Own the ongoing execution and maturation of CPS’s policies in accordance with the National Industrial Security Program • Ensure full compliance with the PA and AOP between CPS and the parent company • Develop and maintain a FOCI mitigation instrument (Security Control Agreement, Special Security Agreement, or equivalent) in coordination with outside counsel on FOCI mitigation matters and any open compliance questions. • Administer personnel security clearance processing end-to-end via JPAS/DISS, including nominations, investigations, and visit certifications. • Lead Collibra's Insider Threat Program, including a multi-disciplinary hub and reporting mechanisms. • Serve as a trusted advisor to the General Manager and the GSC senior leadership on all security and compliance matters related to the government business. • Coordinate incident investigations involving potential unauthorized disclosure, fraud, or insider threat, and ensure prompt reporting to GSC and DCSA as required.