Senior Regulatory Affairs Associate

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.

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.

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

Project Management & Execution

Regulatory Knowledge (EU CTR & Global Submissions)

Risk & Issue Management

Stakeholder Engagement

Strong communication and problem-solving skills

Adaptability, resilience, and teamwork