RA GDD Associate - Kuwait

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We are looking for Regulatory Affairs Associate to join our team in Kuwait who
will be responsible for the registration of new drug products, the maintenance
of registration of approved drug products and the maintenance of RA-GDD
compliance KPIs as per NVS guidance in order to ensure viability of these
products in the marketplace.

Major accountabilities for this role will be :

• 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-GDD manager/Head).


• Close FU internally, with supervision, to reply to the enquiries received from the HA about the variations and renewal applications


• Coordinate with 3rd party suppliers for reference / related substance requests from the MOH.


• 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-GDD 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-GDD database accurate and updated: Dragon


• Comply with all the mandatory RA-GDD training and Maintain updated records of RA-GDD 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 including:


• Dragon /RA-GDD database updates and verification.


• Registration and implementation of labelling changes.


• Preparation for Submission of Risk Management plans (RMP) and Periodic Safety Update Reports (PSURs).


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  Ensure preparation for submission of new Safety updates received from RA-GDD Global.

  
  


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  With Supervision, Update logistics with the RA-GDD related information for the completion of Notification of Introduction (NOI).

  
  


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  Monthly reporting of the activity to the RA-GDD Manager/Head

  
  


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  Assist Medical Information and Quality Assurance with product detail requests wherever feasible. Assist Training Manager with Product Information training requirements wherever feasible.

  
  


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  Request all required documentation concerning manufacturing site registration from Basel and support team in India
  Commitment to Diversity & Inclusion:
  Novartis is committed to building an outstanding, inclusive work environment
  and diverse teams representative of the patients and communities we serve.
  Minimum requirements

  
  


• ‎1-‎3 years' experience as an associate in regulatory affairs dealing with a wide variety of registration projects and issues.


• 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.


• Kuwaiti Nationals will be preferred.
  Division
  Global Drug Development
  Business Unit
  REG AFFAIRS GDD
  Country
  Kuwait
  Work Location
  Kuwait City
  Company/Legal Entity
  Novartis Kuwait Ltd.
  Functional Area
  Research & Development
  Job Type
  Full Time
  Employment Type
  Regular
  Shift Work
  No
  Early Talent
  No