Regulatory Affair Project Excellence

• To be incharge in registration of all new products of project & ensure these new products comply with the regulations of the local Drug Administration Vietnam ( DAV) of Ministry of Health.
• Keeping abreast of international legislation, guidelines and customer practices. (e.g in ASEAN Contries with ACTD) and dealing with local authorities for the updated, common practices.
• Lliaising with, and making presentations to, regulatory authorities; negotiating with regulatory authorities for marketing authorisation;
• Monitoring and setting timelines for licence variations and renewal approvals: preparing submissions of licence variations and renewals to strict deadlines; Developing and writing clear arguments and explanations for new product licences and licence renewals;
• Advising scientists and manufacturers on regulatory requirements;
• Reviewing company practices and providing advice on changes to systems; Undertaking and managing regulatory inspections.
• Clearly understanding the company registration/ regulatory process/ SOP and software or third party service (accessible product labels and patient information leaflets; developing product trials and interpreting trial data, specifying storage, labelling and packaging requirements.
• Providing strategic advice to senior management, project managing teams of colleagues involved with the development of new products;
• Involving to the product forecasts, supply chain related to changes of manufacturing sites, production altenatives, registration/renewal milestones.
• Supporting marketing team for promotional materials, marketing event papers for license/ approval.
• Build professional relationships with medical experts to enhancing the partnership, and effectively communicate product / disease-based scientific information - providing medical options to customers.
• Beyond registration, RAE has to ensure compliance with reporting responsibilities and input into the clinical and commercial debate on how the product will develop further.