Regulatory Affairs Executive

11 hours ago

Subang Jaya Selangor, Malaysia Gentle Supreme Sdn Bhd Full time

Job Summary

The Regulatory Affairs Executive plays a key role in ensuring the company's products and operations comply with regulatory requirements and industry standards. This role includes the preparation of registration dossiers, coordination with authorities, and active support in legal matters such as trademark registration. The position is critical in supporting market access, product compliance, and brand protection.

Key Responsibilities

  • Prepare and submit product registration dossiers to relevant regulatory authorities (e.g., NPRA, MOH, MDA) for approval and renewals.
  • Monitor and ensure compliance with local and international regulatory requirements.
  • Liaise with regulatory agencies, certification bodies, and internal stakeholders to ensure timely approvals and responses to inquiries.
  • Maintain updated regulatory documentation, approvals, licenses, and internal tracking systems.
  • Support in trademark registration processes, including coordination with legal counsel or trademark agents, submission of applications, renewals, and tracking of status.
  • Review and validate product labels, packaging, promotional materials, and technical documents to ensure regulatory compliance.
  • Assist in regulatory aspects of new product development, product variation, and post-marketing surveillance.
  • Support internal and external audits related to regulatory and compliance matters.
  • Stay informed on relevant laws, regulatory changes, and industry updates.
  • Prepare periodic reports and summaries for internal use or regulatory submission.

Requirements

  • Bachelor's Degree in Legal, Chemistry, Intellectual Property Law or related discipline.
  • 3–4 years of experience in regulatory affairs or compliance roles.
  • Familiar with Malaysian regulatory frameworks and agencies such as MOH, NPRA, MDA, and MyIPO (for trademarks).
  • Good understanding of regulatory documentation, product registration, and compliance standards.
  • Strong attention to detail, analytical, and organizational skills.

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