Global CTA Strategy Lead - Regulatory Submissions

ANTER CONSULTING PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

ANTER CONSULTING PTE. LTD. seeks a Senior Specialist, Clinical Trial Strategy & Submissions (CTS) to provide global regulatory expertise for clinical trials and to interface between global functions and regional affiliates.

The role demands hands-on CTA management, regulatory strategy input, and SME guidance on EU CTR submissions, with a focus on cross‑functional collaboration and compliance across development programs.

Qualifications

• CTA experience (3–5 years) with global submissions preferred.
• Experience working within a complex cross-cultural matrix.
• Deep understanding of global regulatory frameworks including EU CTR.

Responsibilities

• Manage CTAs end-to-end, coordinate documentation for initial CTAs and lifecycle activities.
• Provide regulatory submission strategies and input into key documents (IBs, protocols).
• Serve as SME on EU CTR submissions and platform trial designs.
• Lead scientific advice procedures and advise study teams on timing.
• Ensure CTA processes meet timelines and quality standards; monitor milestones.
• Maintain regulatory intelligence and tracking databases for compliance.
• Support inspection readiness and provide operational support for CTS team.

Skills

Project management

Cross-cultural collaboration

Regulatory knowledge

English communication

Problem solving

Proactive approach

Education

Bachelor's degree in Life Sciences

Master’s or Ph.D. preferred

Tools

MS Word

Excel

PowerPoint

Adobe Acrobat

Global regulatory databases/trackers

Job description

ANTER CONSULTING PTE. LTD. seeks a Senior Specialist, Clinical Trial Strategy & Submissions (CTS) to provide global regulatory expertise for clinical trials and to interface between global functions and regional affiliates.

The role demands hands-on CTA management, regulatory strategy input, and SME guidance on EU CTR submissions, with a focus on cross‑functional collaboration and compliance across development programs.