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 setting
* Familiarity with clinical trials and regulatory processes

Key Skills:

* Project Management & Execution
* Regulatory Knowledge (EU C

📌 Senior Regulatory Affairs Associate- Clinical Trial Application (Bengaluru)
🏢 Parexel
📍 Bengaluru