Experience

Zinpro Corporation

• United States
• Food and Beverage Manufacturing
• 200 - 300 Employee

• Regulatory Manager - Europe

  • Oct 2021 - Present



Andrés Pintaluba SA, APSA

• Spain
• Veterinary Services
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Oct 2006 - Oct 2021

  Most of my work focuses on developing documentation on the quality, safety and efficacy of medicinal products, from their inception in pharmaceutical development to the evaluation and approval phase by the competent authorities, including for preparation and dispatch of documentation, question phase management and oral presentation of motions for resolutions.During these years I have successfully completed more than a dozen projects, most of them European procedures with up to 12 countries involved, so I know first-hand the requirements and peculiarities of many European competent authorities.I also have extensive experience in laboratory work, mainly in the areas of drug quality: development and validation of analytical methods and sample analysis.Managing ecotoxicity studies is another of my skills, since I am usually in charge of assessing and approving the study plans and reports. I also carry out the environmental impact assessment of the medicinal product.I provide support in pharmacovigilance tasks such as periodic safety reporting or assessment and monitoring of adverse effects.I use my knowledge in various programming languages and databases in the development of an electronic documentation management system or the creation and maintenance of pharmacovigilance databases.Other responsibilities include assessing drug user safety, comparative studies of dissolution profile or patent search.



SP Veterinaria

• Regulatory Affairs

  • Jul 2001 - Oct 2006

  Development of Quality part of Marketing Authorisation Application, including: development pharmaceuticals and analysis of development samples, assessment on the stability of the medicinal product, validation of manufacturing process, assessment on the quality of starting materials (ASMF), development and validation of analytical methods and establishment of specifications of the finished product. Development of Quality part of Marketing Authorisation Application, including: development pharmaceuticals and analysis of development samples, assessment on the stability of the medicinal product, validation of manufacturing process, assessment on the quality of starting materials (ASMF), development and validation of analytical methods and establishment of specifications of the finished product.