| Develop regulatory affairs and quality assurance team and
provide team leadership; Define and implement the regulatory strategy for new products introduction; Obtain administrative authorization from the local health authorities to put the drug on the market; Maintain all regulatory files for new products in accordance with health authorities requirements and timelines; Maintain all regulatory files for product renewal and line extensions in accordance with health authorities requirements and timelines; Validate promotional communication materials in line with health authority requirements and legislations; Keep good relationship with local health authorities; Provide advice and advance warning on potential regulatory risks and propose preventive or corrective measures accordingly; Put forward a pharmaco-economic strategy to obtain the best pricing of the product; Assist in the resolution of GCP, GLP and GMP issues; Provide guidance and training to management and staff regarding clinical trials and the implementation of GCP, GLP and GMP in collaboration with the quality assurance / quality control unit. |
