Medical Department

	Registration Officers
	Clinical Safety
	Clinical Trials
	Medical Director

REGISTRATION OFFICERS
To direct the registration and manage implementation of approvals from the Irish Medicines Board for Novartis products within various therapeutic areas for the Irish Market in order to meet overall company objectives.

Registration Officers Key Tasks:

• Facilitating the rapid approval of new products, indications and dosage strengths for the Irish market.
• Maintenance of existing Product Licences (renewals, variations and Basic Prescribing Information (BPI) updates) to comply with the highest ethical standards in the industry. The total number of Licences to be maintained is around 150.
• Participate and support Headquarters as a Euro-team member for applications filed under the European Community (EC) systems, namely Mutual Recognition and Centralised procedures (MRP and CP).
• Attend and contribute to International registration meetings and update relevant office staff of key information from these meetings.
• Approve Irish specific artwork and leaflets for consistency with the licence and inform Artwork Design and Planning when the changes need to be implemented.
• Co-ordinate the logistical implementation of any registration changes.
  
• Review and approve promotional material for consistency with the licence.
• Work with marketing colleagues to inform them of new indications, changes in indications, changes in product specifications, changes in licensing, new products and progress with development of new products.
• Submit and support clinical trial applications to the Irish Medicines Board (IMB). Liase with Novartis UK International Clinical Research Organisation (ICRO).
• Participate as members of the Irish Pharmaceutical Healthcare Association (IPHA) Regulatory Task Force with regard to good regulatory practice.
• Participate in the implementation of procedures and quality indicators.