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 robust 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)
Solid 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