• Developing and leading global regulatory strategies to support business objectives • Leading and assisting with submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc. • Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale • Developing and executing premarket and postmarket regulatory project plans and strategies, including assessments of change controls • Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal records • Work closely with business leadership to ensure regulatory strategy aligns with commercial goals • Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently

• Serve as a technical leader and subject matter expert focused on SOC 2 readiness and examination audits. • Ensure client satisfaction and efficient execution of engagement plans. • Coach and advise team members in executing SOC 2 compliance tasks. • Build client relationships grounded in understanding their operations and compliance needs. • Deliver top-notch services in business, IT, and security risk management.

• Build collaborative relationships and serve as a trusted advisor to divisional leadership, laboratory operations, phlebotomy, and sales/commercial personnel at all levels • Provide proactive compliance guidance and support on a broad range of clinical laboratory arrangements with hospitals/health systems, physicians, medical clinics, and other clients • Lead compliance-related due diligence and integration activities for health system and regional laboratory acquisitions within the division • Engage with other departments, including Human Resources, Marketing, Finance, Information Technology, Revenue Cycle Management, Real Estate, Law/Contracts, Science and Technology, and Quality to advance cross-functional initiatives and projects in support of Labcorp Diagnostics compliance and business objectives • Conduct thorough internal investigations into potential compliance program violations and other allegations of misconduct • Implement compliance training programs and educational opportunities for new and existing employees to ensure a thorough understanding of relevant laws, regulations, and Labcorp policies and procedures • Support compliance audit activities within the division to identify gaps and areas for improvement

Title: Senior Reg Affairs Specialist - CTA (Clinical Research Field) Location: Remote Spain Full time Remote We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department – Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects. You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients. You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings. The following skills are required to be successful in this position: - preparation and assembly of global regulatory submissions - interacting with sponsors, - review and assess clinical trial regulatory documents, - review and assess scientific literature. - manages project teams and preparation - participate in launch meetings, review meetings and project team meetings. Optional skills: - Experience with bid defense meetings Education and experience: - Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification - Previous experience that provides the knowledge, skills, and abilities to perform the job - Knowledge of the global clinical trials landscape Knowledge, Skills and Abilities: - Excellent command of the English language (written and oral) as well as local language where applicable - Excellent attention to detail and quality as well as excellent editorial/proofreading skills - Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments - Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies - Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects - Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables - Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines - Excellent analytical, investigative and problem-solving skills What we offer: As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.