Senior Regulatory Affairs Associate- Clinical Trial Application

**When our values align, there's no limit to what we can achieve.**   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Summary: ============ The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW) regions. This role ensures timely, high-quality, and compliant submissions through effective cross-functional collaboration, proactive risk management, and strong regulatory expertise. Key Responsibilities: * Lead end-to-end CTA project management across multiple studies and countries * Plan, track, and deliver submissions aligned with timelines and regulatory requirements * Manage risks, dependencies, and complexities in global regulatory environments * Apply knowledge of EU CTR and ROW CTA requirements * Manage core clinical and regulatory documentation * Collaborate with cross-functional global teams * Build and maintain stakeholder relationships and resolve conflicts * Monitor KPIs related to timelines and deliverable quality * Identify risks and lead quality investigations as needed Qualifications & Experience: * Bachelor’s degree in Life Sciences, Pharmacy, or related field * Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar * Experience in Clinical Trial Application submissions (EU CTR & ROW) * Strong project management experience in a global/matrix environment * Familiarity with clinical trials and regulatory processes Key Skills: * Project Management & Execution * Regulatory Knowledge (EU CTR & Global Submissions) * Risk & Issue Management * Stakeholder Engagement * Strong communication and problem-solving skills * Adaptability, resilience, and teamwork