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)

- Solid 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

📌 Senior Regulatory Affairs Associate (Serilingampalle (M))
🏢 Parexel
📍 Serilingampalle (M)