Regulatory Affairs Executive

1 week ago


Subang Jaya Selangor, Malaysia Delfi Marketing Sdn Bhd Full time

Key Responsibilities

  • Prepare, review, and submit regulatory applications to regulatory authorities.
  • Monitor and track submission progress, approvals, renewals, and variations.
  • Maintain up-to-date regulatory documentation, records, and filing.
  • Review product labels, artworks, and related materials for regulatory compliance.
  • Conduct routine literature searches for safety updates and maintain post-market safety documentation.
  • Monitor regulatory changes and ensure continued compliance with local regulations.

Requirements

  • Bachelor's Degree in Science, Pharmacy, Biotechnology, or a related field.
  • 2–3 years of regulatory affairs experience preferred (strongly motivated fresh graduates may also be considered).
  • Ability to understand and interpret regulatory guidelines and technical documents with strong analytical skills.
  • Excellent attention to detail and proficiency in document filing and record management.
  • Strong written and verbal communication skills.
  • Self-motivated, responsible, and able to manage multiple tasks and meet deadlines independently.
  • Knowledge of regulatory guidelines for pharmaceuticals, medical devices, cosmetics, and/or food products (preferred).
  • Familiarity with pharmacovigilance and post-market surveillance processes is a plus.


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