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Regulatory Affairs Manager

1 week ago

Subang Jaya, Selangor, Malaysia Roche Services (Asia Pacific) Sdn Bhd Full time
About the Job

We're looking for a talented Audit and Compliance Specialist to join our team at Roche Services (Asia Pacific) Sdn Bhd. This role involves working closely with our business functions to ensure that all operations are conducted in accordance with relevant laws, regulations, and standards.

Key Tasks
  • Maintain close monitoring of trends and changes in global, regional, and local legal, industry, and regulatory requirements and standards.
  • Take ownership of internal policies, procedures, SOPs, and compliance databases to ensure compliance with applicable laws, standards, and regulations.
  • Maintain compliance touchpoints with the latest information and documentation.
  • Ensure adequate risk and opportunity identification, assessment, and management.
  • Act as key contact for all compliance systems and processes, and lead projects to improve compliance processes and efficiency.
Responsibilities
  • Implement and maintain training programs, compliance initiatives, and monitoring programs covering people, processes, and platforms.
  • Closely collaborate with business functions to drive business within a framework of high compliance standards.
  • Provide guidance and advisory on compliance matters to the organization.
  • Lead local investigations and ensure adequate handling and documentation of non-compliance.
  • Support the People & Culture team to manage issues related to business ethics, conflict of interest, integrity, and the like.
Qualifications
  • Bachelor's degree with at least 5 to 7 years of relevant experience in compliance, audit, legal, quality, risk management, or a related function.
  • Experience in the pharmaceutical or healthcare industry is preferred but not mandatory.
  • Strong knowledge of regulations, teamwork, communication, business acumen, market awareness, and pragmatism.