Regulatory Compliance Specialist

1 week ago


Singapur, Singapore Oracle Full time
Job Summary

We are seeking a highly skilled Regulatory Compliance Consultant to support Oracle Life Sciences Global ISO certifications and ensure adherence to various regulatory requirements.

Key Responsibilities
  • Implement established quality processes and ensure their adequate application among Asia/Pacific teams.
  • Ensure all projects are conducted in accordance with Oracle Life Sciences SOPs.
  • Perform internal and external auditing based on Oracle Life Science's quality system standards, including ISO 9001:2015 and ISO 20252:2019.
  • Ensure compliance with pharmacovigilance requirements.
  • Communicate team goals that support and advance team and organizational compliance objectives.
  • Influence diverse stakeholder groups and drive acceptance of policies, practices, and procedures.
  • Identify, propose, and support quality and process improvement initiatives.
  • Assist with training, guidance, and feedback to encourage success and promote associate growth.
  • Maintain quality and compliance documentation, including SOPs, templates, and working instructions.
  • Organize and deliver trainings from clients and/or industry guideline trainings internally and externally.
Requirements

The ideal candidate will have a strong background in regulatory compliance and quality assurance, with experience in implementing quality processes and ensuring compliance with regulatory requirements.

They will also have excellent communication and influencing skills, with the ability to drive acceptance of policies and procedures among diverse stakeholder groups.

A bachelor's degree in a relevant field, such as life sciences or business, is required, and a master's degree is preferred.



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