Regulatory Affairs Associate

Job description

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 3+ 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