Experience

UQUIFA

• Spain
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Regulatory Affairs

  • Jan 2005 - Present

  As responsible of different products and specific countries in all aspects related to the registration of generic products, the main developed tasks are: - Preparation and maintenance of dossiers for health authorities (DMFs, CEPs, amendments, annual reports ,...) in Europe, USA, Korea, Japan and emerging countries to apply the regulations of each one of them. - Support clients to potential deficiencies and points to clarification (Type IA, IB and II variations, MRP, DCP ,...). - Compilation and updating of technical documentation for customers Show less



Farmhispania Group

• Spain
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Regulatory Affairs

  • Mar 2002 - Dec 2004

  Technician in the Quality Assurance / Regulatory Affairs dept. developing aspects of quality management standards based on GMP (batch records, complaints / returns, validations ,...), and all aspects related to the area of regulation. Development and maintenance of dossiers for health authorities (DMFs, CEPs,...), preparation of documentation for clients, and support to customers and reply to MoH in relation to deficiency letters received in connection with different regulatory procedures. Technician in the Quality Assurance / Regulatory Affairs dept. developing aspects of quality management standards based on GMP (batch records, complaints / returns, validations ,...), and all aspects related to the area of regulation. Development and maintenance of dossiers for health authorities (DMFs, CEPs,...), preparation of documentation for clients, and support to customers and reply to MoH in relation to deficiency letters received in connection with different regulatory procedures.