Director, Global Compliance and Strategy APAC

Borr Drilling; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading technology company is seeking a regulatory compliance expert based in Singapore to oversee local regulations affecting clinical trials. The ideal candidate will engage with regulatory bodies, manage quality incident processes, and ensure compliance within various clinical trial activities, all while collaborating with internal teams across the organization. Fluency in Mandarin and the ability to work independently are essential for this role.

Qualifications

• Strong understanding of regulations governing clinical trials, including ICH Good Clinical Practices.
• Extensive experience in clinical trial processes and technologies, specifically TMF/SMF.
• Fluent in Mandarin and English (reading, writing, speaking).

Responsibilities

• Engage with local regulatory agencies and government authorities.
• Supervise team resources within the Asia region.
• Provide operational support to quality management programs.

Skills

Compliance expertise

Regulatory knowledge

Clinical trial processes

Inspection management

Data privacy and security

Job description

With Medidata’s continued growth in the Asia regions (including Japan, China, Korea, Singapore, and Australia), the ideal candidate will serve as a geographically local resource focusing on matters related to Medidata’s Quality Management System and regulatory strategy.

Reporting directly to the SVP, Global Compliance and Strategy (“GCS”), the ideal candidate will:

• Engage with key local regulatory agencies (e.g., PMDA (Japan), NMPA (China), MFDS (Korea), HSA (Singapore)) and government authorities (e.g., China HGRAC) to ensure that Medidata’s interests as a Software as a Service (SaaS) technology company serving regulated companies are considered in regulatory guidance documents and agency perceptions.
• Interact directly with customers to address quality and regulatory matters relevant to the use of technology in clinical trials.
• Collaborate cross-functionally with other Medidata business units (e.g., Legal, Information Technology, Product Development) to contribute to achieving Medidata’s goals, business plan, and long-term strategy.
• Supervise team resources located within the Asia region.

The ideal candidate will also have responsibilities for providing operational support to GCS-managed programs (e.g., quality incident management, internal quality system audits, customer audit needs).

• Have a strong understanding of regulations governing clinical trials, including:
• Framework guidelines such as ICH Good Clinical Practices (GCP) and regional distinctions.
• Clinical Regulations (e.g., Human Genetic Resource Management Regulation, CFDA Technical Guidelines on Accepting Overseas Clinical Trial Data of Medical Devices, etc.).
• Regulations on data management in clinical trials.
• Computer Systems Validation.

Possess extensive experience in clinical trial processes and technologies, including a strong working knowledge of trial master file and site master files (TMF/SMF) and eTMF.

Demonstrate experience as a compliance functional expert, especially regarding clinical processes and technologies, with proven ability to present to senior executives.

Be familiar with quality systems processes and enablement, including auditing.

Understand data privacy and security requirements under China Cybersecurity Law(s).

Have inspection management experience.

Proven track record of working independently to evaluate requirements and propose solutions.

Be fluent in Mandarin and English (reading, writing, speaking).

Reside in Singapore and be able to be present in the local office 3x/week.

Be able to travel within the region.

Inclusion statement

As a game-changer in sustainable technology and innovation, Dassault Systèmes is striving to build more inclusive and diverse teams across the globe. We believe that our people are our most valuable asset, and we want all employees to feel empowered to bring their whole selves to work every day. Our goal is for our people to feel a sense of pride and belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future.