Compliance Officer Regulatory Asia

3 days ago


Singapore Private Advertiser Full time

Role Summary

The Private Advertiser is seeking a Compliance Officer to oversee the product registrations and regulatory pathways in Asia Pacific. This role demands strong expertise in ensuring compliance with Asia Pacific regulations, influencing key decision-making processes, and contributing to enterprise-wide impact.

Main Responsibilities

  • Independently manage and execute all aspects of successful preparation, submission, and timely approval of applications, variations, post-approval reporting obligations, and general product life cycle management of assigned program.
  • Develop, implement, and maintain regulatory strategies for the products in line with the Company's global objectives and local requirements.
  • Monitor regulatory changes and emerging trends in the space where the Company operates.

Requirements

  • A degree in life sciences, pharmacy, or a related field preferred.
  • Minimum 8 years of regulatory affairs experience in the healthcare industry in Asia Pacific.
  • Experience with oncology clinical trials and regulatory requirements for investigational new drugs.
  • Strong problem-solving skills and ability to navigate complex regulatory environments.


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