Cristina Blanco Email and Phone Number

Initial development stages regulatory strategy for biotechnological molecules (pre-IND, ODD, SA, PIP, ...)US/EMA mAb biosimilar pre-submission activities, gap analysis, Regulatory strategy roadmap.Marketing Authorizations strategy coordination, document preparation and / or revision for submission to Health Authorities. Acts as a Regulatory Team Leader on complex projects, which includes technical writing and revision for a stand-alone project. Gap analysis, roadmap for regulatory… Show more Initial development stages regulatory strategy for biotechnological molecules (pre-IND, ODD, SA, PIP, ...)US/EMA mAb biosimilar pre-submission activities, gap analysis, Regulatory strategy roadmap.Marketing Authorizations strategy coordination, document preparation and / or revision for submission to Health Authorities. Acts as a Regulatory Team Leader on complex projects, which includes technical writing and revision for a stand-alone project. Gap analysis, roadmap for regulatory strategy.Establishes relationships with many customers; meet face to face without rest of team to discuss regulatory issues, options proposed and doubts resolution for the regulatory strategy proposal. Adopts a proactive and flexible approach to resolve any issues.Give guidance to junior colleagues, including feedback on the quality of technical documents, and assists in their training and development.Support global regulatory or technical initiatives and act as a regional representative on a cross-functional initiative. Show less

To manage a regulatory and/or technical project, both for internal and external clients. To provide strategic regulatory and/or technical consultancy on a variety of projects.

Marketing authorizations strategy coordination.Technical responsible for dossier preparation, DCP management, deficiency letters responses and national steps for around 15 different hormonal products, including solids, soft gelatin capsules, vaginal delivery systems and injectable products.Variation package preparation for quality part changes.EU life product process- variations, renewals and maintenance of the dossier.International dossier preparation and registration, mainly… Show more Marketing authorizations strategy coordination.Technical responsible for dossier preparation, DCP management, deficiency letters responses and national steps for around 15 different hormonal products, including solids, soft gelatin capsules, vaginal delivery systems and injectable products.Variation package preparation for quality part changes.EU life product process- variations, renewals and maintenance of the dossier.International dossier preparation and registration, mainly for US, Canada, Brazil and many other countries in the world.Broad experience in HA communications. International coordination for marketing authorizations management as CMO site for multiple pharmaceutical companies as Novartis/Sandoz, Ratiopharm, Actavis, Amneal, Apotex, Fresenius Kabi, Glenmark, Mylan, Alvogen, Egis, Zentiva, Egis, Polpharma... Show less

DMFs compilation and submissions in Europe, USA, Canada, etc.GMP audits, by clients and Health authorities.Quality Assurance and Quality Control SOPs elaboration and implementation.

Research and development of active pharmaceutical ingredients: design and development of synthesis pathways, including analytical methods development and validation. Technology transfer from lab to pilot scale and process validation. Two granted patents as co-inventor.