Regulatory Affairs Associate
India, Remote 职位编号 R0000042663 类别 Regulatory / Consulting关于这个职位
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
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