Acerca de Conchi Torrejón
Over 9 years of professional experience as Regulatory Affairs Officer, working in cross-functional teams across Oncology on marketed products and leading regulatory submissions to EMA, and supporting the preparation of GI EMA pipeline meeting and in the preparation of EU Regulatory Strategy for the development of microbiome product in Gastrointestinal Therapeutic Area.
Specialized in:
• Preparation and submission of Marketing Authorisation Application (Centralised procedure – EMA).
• Achieved submission and approval of orphan designation.
• Preparation and submission of scientific advice meetings.
• Provision of development support – Member of New Indications Working group.
• Submission of INN and ATC applications to World Health Organization.
• Preparation of IND, iPSP, RMAT and SPA/SPA amendments (FDA).
• Evaluation of regulatory strategies, discussion of alternatives and decision taken for the development of the product.
• Planned and prepared to deliver complex submissions throughout the product life-cycle.
Also has 3 years of professional experience as an independent consultant to provide Regulatory advice to Pharmaceutical companies for the development of regulatory strategies to facilitate rapid development and registration of Chemicals and Biological products. Specialised in Advance Therapy Products (cell therapy): autologous and allogeneic cell therapy products.
Global regulatory expert (EU, FDA, Canada, etc) in the preparation and review of quality, nonclinical, safety and clinical documentation for use in regulatory submissions.
Education
Degree in Pharmacy. University of Alcalá de Henares.
Master in Drug Research, Development and Innovation. Complutense University of Madrid.
Research Sufficiency in Experimental Pharmacology.
Postgraduate degree in Regulatory Affairs. Official College of Pharmacists of Madrid.
Postgraduate in Quality System in Pharmaceutical Industry. Autonomous University of Barcelona.
MBA. University of La Rioja.
Languages: Spanish and English.
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