Pablo GarcÃa Fernández
Regulatory Affairs Officer at QualitecFarma
pharma
Qualicaps
China
Biography
Senior Regulatory Affairs and Pharmacovigilance officer. Expert in molecular biology with more than 8 years of experience in basic research within the biopharmaceutical industry, and more than 5 years as Regulatory Affairs consultant. Communication skills, high capacity for teamwork and learning ability. High experience in disease pathways, network biology, quality assurance, regulatory affairs and pharmacovigilance.
Research Interest
Ensure regulations compliance (National and European regulations) for all company products. eCTD reformat Collect and evaluate scientific data. Prepare labelling, PIL, SmPC and mockups of medicinal products, and adaptation to current QRDs. Provide strategic advice throughout the development of new products. Managing teems of colleagues involved with the development of new dossiers.