Senior Regulatory Affairs Associate - Clinical Trial Application Management

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

Experience Level

Senior Level