RA GDD Associate UAE

Job description

Job Description

• New Product Registrations – With supervision, evaluate, and prepare drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favourable outcome
• Maintenance of registered products – With supervision, maintain registration of currently approved products (initiation and preparation of variation/ and renewal applications as per the plan communicated from the RA manager/Head).
• Close FU internally, with supervision, to reply to the enquiries received from the HA about the variations and renewal applications
• Initiate and prepare, with supervision, new or renewal registration of manufacturing site as per new and mature products registration plan in the assigned countries.
• Update local archives for manufacturing site new/renewal, variation update, renewal update
• Coordinate with RA manager/head to ensure correct and speedy implementation / consignments as per the approved applications (variation/ renewal/ site transfer/ site registration/leaflet update).
• Maintain the internal RA database accurate and updated: Dragon
• Comply with all the mandatory RA training and Maintain updated records of RA training/compliance training
• Product Information – With supervision, develop and maintain product information ( LEAFLET UPDATE) ensuring the correct distribution and use of the approved versions of these documents
• Relationships within and outside the company - Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with health authority.
• With Supervision, Review PPMS and ensure AQWA Launch request are prepared and launched on time.
• With Supervision, Ensure full support to Global regulatory compliance initiatives
• With Supervision, Update logistics with the RA related information for the completion of Notification of Introduction (NOI).
• Monthly reporting of the activity to the RA Manager/Head
• Assist Medical Information and Quality Assurance with product detail requests wherever feasible. Assist Training Manager with Product Information training requirements wherever feasible.
• Request all required documentation concerning manufacturing site registration from Basel and support team in India

Desired profile

Minimum requirements

• Tertiary qualified – Pharmacy or Science (majoring in a life science or chemistry) with or without postgraduate qualifications
• Languages: Arabic and English written and spoken are mandatory.
• 1-3 years’ experience as an associate in regulatory affairs dealing with a wide variety of registration projects and issues.