Global Regulatory Clinical Trials Strategist

ALLEGIS GROUP SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Allegis Group Singapore Private Limited seeks a Regulatory Associate to provide global regulatory expertise for Clinical Trials and to serve as the main interface between global functions and affiliates to deliver regulatory strategies and outcomes.

The role requires 3–5 years CTA experience, cross-cultural collaboration, and strong IT skills. You will lead submissions, monitor timelines, and support inspection readiness across a global matrix.

Qualifications

• 3–5 years CTA experience, preferably in global clinical trial submissions.
• Experience across cultures in a complex matrix environment.
• Strong IT skills with MS Word, Excel, PowerPoint, Adobe Acrobat, and global databases.

Responsibilities

• Manage a portfolio of CTAs including preparation and distribution of documentation for new CTAs and maintenance activities.
• Provide advice on submission strategy and country requirements; support regulatory submission preparation.
• Serve as SME on EU CTR submissions; guide cross-functional teams and define CTR transition strategies.
• Lead CTA-specific scientific advice procedures and manage options/strategies for utilization.
• Review documents related to clinical trial submissions (IB, Protocols) and input on CTR processes.
• Ensure approved CTA processes are followed within agreed timelines.
• Understand CTR processes and requirements.
• Monitor milestones and communicate issues/changes to stakeholders and management.
• Support inspection readiness activities as applicable.
• Maintain regulatory intelligence awareness and advise stakeholders accordingly.
• Ensure databases and trackers are populated on time; provide operational support for regulatory systems.
• Provide technical support for document preparation (Excel, PowerPoint).
• Undertake training to ensure compliance with processes.
• Provide CTS team operational support.
• Comply with policies to meet statutory, quality and business requirements.
• This position reports to the Associate Director, CTS.

Skills

Regulatory submissions

Cross-cultural collaboration

Project management

Communication skills

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

MS Word

Excel

PowerPoint

Adobe Acrobat

Job description

Allegis Group Singapore Private Limited seeks a Regulatory Associate to provide global regulatory expertise for Clinical Trials and to serve as the main interface between global functions and affiliates to deliver regulatory strategies and outcomes.

The role requires 3–5 years CTA experience, cross-cultural collaboration, and strong IT skills. You will lead submissions, monitor timelines, and support inspection readiness across a global matrix.