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.

• Monitor for relevant regulatory developments across all 50 states and the SEC, ensuring timely awareness of new compliance issues, rule proposals, and comment periods. • Develop and maintain XYPN’s advocacy and policy roadmap, including issue tracking, prioritization, engagement status, and next steps. • Partner with the Managing Director and Executive Team to shape advocacy priorities and provide informed recommendations on engagement opportunities. • Develop a deep understanding of XYPN member firms, industry trends, and emerging regulatory issues to inform advocacy priorities and identify opportunities to influence regulation. • Develop consistent channels for gathering member feedback, case studies, and practical examples to inform XYPN’s advocacy positions. • Coordinate member-facing communications regarding advocacy initiatives, regulatory updates, and policy resources. • Partner with members to prepare for legislative or regulatory hearings, meetings with state regulators and legislators, and other advocacy opportunities, including testimony and supporting materials. • Develop and deliver educational sessions for legislators, regulators, XYPN members, and industry groups on regulatory trends, RIA business models, operational realities, and the impact of proposed regulation. • Build productive relationships with regulators, industry stakeholders, advocacy partners, and member firms to support ongoing dialogue and collaboration. • Coordinate strategic partnerships with industry associations, including IAA, FPA, NAPFA, CFP Board, and other aligned organizations. • Draft policy positions and supporting materials, including comment letters, white papers, policy briefs, issue summaries, case studies, and testimony. • Lead execution of advocacy activity in individual states, with the SEC, and with NASAA, including preparing formal responses to proposed regulations, policies, and rulemaking initiatives. • Represent XYPN in meetings with state and SEC regulatory staff, NASAA representatives, and other relevant stakeholders on advocacy and rulemaking matters. • Attend industry conferences, regulatory events, hearings, symposia, and working groups to strengthen relationships and stay engaged in evolving policy conversations. • Accountable for reporting on activity and impact related metrics ranging from: Policy issues being tracked, Comment letters submitted, Meetings with regulators, Evidenced impact on policy changes.

• Lead the strategy and response for complex customer cybersecurity contract proposals (MSAs, SOWs, and RFPs) • Serve as the authoritative voice in contract negotiations, balancing risk, liability, and market competitiveness • Deploy AI-assisted tools to automate and accelerate responses to security questionnaires, contract reviews, and risk analyses • Partner with Legal, Finance, and Sales to align cybersecurity contract positions with deal strategy • Monitor and interpret global cybersecurity regulations (NIS2, NERC CIP, IEC 62443, EU CRA, etc.) into actionable business guidance • Design and operationalize a regulatory readiness framework, helping business units assess gaps and build remediation roadmaps • Utilize AI-enabled tools for continuous gap analysis and prioritized compliance reporting • Represent GE Vernova’s cybersecurity regulatory perspective in industry and government forums • Act as the HQ liaison for commercial and regulatory matters, ensuring a consistent enterprise security posture • Harmonize cybersecurity obligations across business units for shared customers to reduce conflict and duplication • Build intelligent knowledge management systems and AI-augmented tools to empower business units to self-serve • Establish governance and escalation paths to ensure all engagements align with enterprise policy

• Lead GVH's 10 CFR Part 21 Program • Help develop, resolve, and determine the effectiveness of condition reports • Coordinate and prepare Licensing Topical Reports (LTRs), including preparation of responses to customer and Nuclear Regulatory Commission (NRC) questions • Prepare and review licensing documentation and reports supporting customer License Amendment Request (LAR) applications • Support customer 10 CFR 50.59 reviews, including preparation of Technical Safety Evaluation Reports and working with internal teams evaluating licensing status of various fuel and methodology changes • Interface with customers and regulatory personnel on regulatory issues, and secure applicable permissions and approvals related to project scopes