Role Description:

The DRA Officer works with some independence under limited supervision to provide support to the DRA Manager for maintaining product registration in Hong Kong and Macau. The DRA Officer will take an active role in assessing the speed to which a product is registered and to ensure proper and timely management of regulatory aspects of licenses own by the pharma division of Novartis Hong Kong.

Responsibilities:

• Provides proper and timely registration of products and have contingency plans.
• Provides proper and timely management of product licenses (e.g. on variations, safety updates and renewals) according to global and local regulatory requirements
• Coordinates and plans rehearsals for HA meetings as required
• Contributes to identification of issues, gaps, and trade-offs affecting optimal and timely submission and approval.
• Assists with generating local PIs and ensuring that they are integrated with the global information and regulatory strategy, and are commercially competitive.
• Maintain all DRA related databases and information systems

Qualifications:

• Degree or equivalent in Life Sciences, Pharmacy or Medicine
• Fluent in written and spoken English and Chinese
• 3-5 years’ experience in pharmaceutical industry
• Pharmaceutical industry experience particularly in handling clinical technical dossiers, drug safety and medical data
• Familial with medical terminology and working with large databases
• Analytical, and ability to mitigate risk
• Candidate with less experience will be considered as DRA Officer