research & Regulatory Affairs specialist

1. Regulatory affairs
• Monitoring Vietnam regulatory environment to identify potential future changes and forecast impact to products and business.
• Keeping up-to-date with developments and changes in regulatory affairs; compile and submit the required revisions to dossiers according to the requirements of the new regulations.
• Dossier preparation for Regulatory Submissions.
• Undertaking necessary dossier preparation and timely dispatch for regulatory submission in accordance to regulations: Drug (New registrations, variations, extension, advertising content confirmation dossier); Health supplements (new registrations, variations dossiers), Medical equipment (declared price dossier) ...
• Following dossier, monitor and respond information from authority related to dossiers
• Coordinating translation of the pharmaceutical dossiers when required according to authorities.
• Coordinating with relevant departments during product circulation: provide approval information of products when launching to the market, ensure the conformity of label of products circulating in market, coordinate to resolve related legal issues of the product.
2. Research & Development
• Surveying on competition and market of new products
• Surveying on the suitability of new drug products and factories
• Determining the registrability of the formula with the current regulation.
• Proposing and discussing with stakeholders to research and development new product formula
• Making changes related to product quality, not excluding packaging, labels
• Coordinating with related departments to launch new product to the market: Issues related to product quality
3. Other
• Drafting contracts, product orders, liquidation agreements and relevant adjustment appendices. Follow up the contract performance of the parties
• Undetaking other tasks as required by direct manager