Regulatory Affairs Data Steward

Navitas Life Sciences; Kuala Lumpur; On-site; MYR 100,000 - 125,000; Full time

Job summary

A prominent life sciences company is seeking a Regulatory Affairs professional in Kuala Lumpur. The role requires over 8 years of experience in Regulatory Affairs or Operations, including a solid background in data governance and compliance within the biopharmaceutical industry. Key qualifications include a strong understanding of regulatory systems like Veeva RIM, and the ability to support compliance through data management principles. This position is critical for ensuring that all regulatory requirements are met efficiently.

Qualifications

• 8+ years of experience in Regulatory Affairs or Operations is required.
• At least 3 years of experience in data governance or quality roles.
• Understanding of regulatory submission and compliance requirements.

Skills

Regulatory Affairs experience

Data governance knowledge

Biopharmaceutical industry understanding

Global regulatory compliance

Data management principles

Tools

Veeva RIM

Liquent

Lorenz

Job description

8+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3 years in a data governance, data management, or data quality role.

Qualifications

• Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment
• Strong understanding of global regulatory submission and compliance requirements.
• Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs and support compliance (e.g., Veeva RIM, Liquent, Lorenz).
• Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling
• Strong understanding of data governance principles and best practices, certification in data management or data governance (e.g., ISO IDMP, xEVMPD, SPL).