Senior Regulatory Affairs Associate- Clinical Trial Application
Primary Location: India, Remote 求人ID R0000042639 Category Regulatory / Consulting
About this Role
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 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
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