Regulatory Affairs Executive

2 weeks ago


Sungai Buloh, Selangor, Malaysia Yanling Natural Hygiene Sdn Bhd Full time

Responsibilities:

  • To handle product registration (Traditional Medicine / Natural Product, Health Supplement, & OTC).
  • Liaising and negotiating with regulatory authorities
  • Providing advises about regulations to customers / colleagues
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Keeping up to date with changes in regulatory legislation and guidelines.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Prepare or direct preparation of additional information or responses as requested by regulatory agencies such as post market surveillance.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Prepare responses to customer requests for information, such as product data or written regulatory affairs statements.
  • Recommend changes to company procedures in response to changes in regulations or changes
  • Coordinate recall or market withdrawal activities as necessary.
  • Required to study scientific or clinical papers for supporting claims on product.
  • Able to pay close attention to details and have good reading comprehension on scientific matters.


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