Global Compliance and Strategy APAC Lead

[Company / Industry] Computer software & data solutions / Information Technology & Life Science

[Position] Global Compliance and Strategy Lead

[Function] Compliance and Strategy

[Reporting Line] Director, Global Compliance and Strategy

[Employment Type] Permanent

[Compensation] TBD

[Location] Seoul, Korea

[Global HQ] New York, USA

[Consultant in charge] Simon S. Kim

COMPANY DESCRIPTION:

Global data & solution company dedicated to life sciences / clinical trials market

JOB DESCRIPTION:

• Engage with key local regulatory agencies in the APAC region (e.g. MFDS (Korea), HSA (Singapore), TGA (Australia) etc.) and government authorities if applicable to ensure that the Company’s interest as a Software as a Service (SaaS) technology company serving regulated companies is considered in regulatory guidance documents and agency perceptions

• Interact directly with customers to address quality and regulatory related matters relevant to the use of technology in performing clinical trials

• Collaborate cross-functionally with other Company business units (e.g. Legal, Information Technology, Product Development) to contribute to achieving the Company's goals, business plan, and long-term strategy

• Fulfill the responsibilities for providing operational support to Global Compliance and Strategy managed programs (e.g. quality incident management, internal quality system audits, customer audit/inspection needs)

JOB REQUIREMENTS:

[COMPETENCIES]

• Strong understanding of regulations governing clinical trials, including:

• Framework guidelines including ICH Good Clinical Practices (GCP) and regional distinctions

• Clinical Regulations (e.g. KGCP, specific requirements in South Korea on Clinical trials, MFDS inspections)

• Regulations on data management in clinical trials

• Computer Systems Validation

• Extensive experience in clinical trial processes and technologies, including, but not limited to a strong working knowledge of trial master file and site master files (TMF/SMF) and eTMF

• Understands quality systems processes and enablement including auditing, root cause analysis and CAPA development

• MFDS inspection experience is preferred

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

• Strong teamwork spirit and good communication skills

• Fluent (read, write, speak) in English and Korean

• Residing in Seoul; able to travel within the region.

[EDUCATION & EXPERIENCE]

• Bachelor's degree required with 8 years of experience, 5 years of experience with a Master’s; or equivalent years of experience in the life sciences industry and/or medical/clinical operations

• Requires a minimum of 2 to 3 years of experience in clinical development quality assurance.

If you are interested, please contact simon.kim@rp4rp.com +82-2-6123-0100