Contract Agent, Regulatory Affairs and Organisational Support Unit, European Medicines Agency, EMEA

Job summary
The European Medicines Agency seeks a Contract Agent, Regulatory Affairs and Organisational Support Unit for the Post-Authorisation Evaluation of Medicines for Human Use, (FGIV).

Location: London

Further details

With responsibility, under the Head of Sector for Regulatory Affairs and Organisational Support for:
 
-  Provision of regulatory and procedural advice in relation to the development, evaluation and surveillance of medicinal products for human use, submitted through the Centralised Procedure from early pre-submission to post-authorisation follow up.  
-  Provision of regulatory and procedural advice in relation to referrals for Non-Centrally Authorised Products.  
-  Provision of regulatory support to the Committee for Medicinal Products for Human Use (CHMP) and its associated Working Parties and expert Groups, the Committee for Orphan Medicinal Products (COMP) and the Paediatric Committee (PDCO)
-  Responsible for ensuring co-ordination in the application and interpretation of legislation to the operations of the EMEA in co-operation with other regulatory affairs/legal colleagues and where necessary the European Commission.  
-  Provision of regulatory and procedural guidance in compliance with community legislation to Agency staff, all the Human Scientific Committees and their working parties.  
-  Responsible for the development of regulatory and procedural guidance through internal and external Standard Operating Procedures, Guidance documents, etc.  
-  Provision of regulatory advice in relation to the new pharmaceutical legislation and development of EMEA policy in emerging topics of interest e.g. borderline products, advanced therapies, pharmacovigilance.