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