Regulatory Affairs Associate

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.

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

Experience Level

Mid Level