Regulatory Affairs Executive

Responsibilities: 1.     To handle product registration (Traditional Medicine / Natural Product, Health Supplement, & OTC). 2.     Liaising and negotiating with regulatory authorities  3.     Providing advises about regulations to customers / colleagues 4.     Coordinate efforts associated with the preparation of regulatory documents or submissions.  5.     Keeping up to date with changes in regulatory legislation and guidelines.   6.     Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.  7.     Prepare or direct preparation of additional information or responses as requested by regulatory agencies such as post market surveillance.  8.     Direct the collection and preparation of laboratory samples as requested by regulatory agencies  9.     Prepare or maintain technical files as necessary to obtain and sustain product approval.  10.  Prepare responses to customer requests for information, such as product data or written regulatory affairs statements.  11.  Recommend changes to company procedures in response to changes in regulations or changes  12.  Coordinate recall or market withdrawal activities as necessary.  13.  Required to study scientific or clinical papers for supporting claims on product.  14.  Able to pay close attention to details and have good reading comprehension on scientific matters.