Senior Regulatory Affairs Associate- Clinical Trial Application

Job description

**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