Anuya Aras

Project Lead for multiple projects including Compassionate Use Programs (CUP) in Germany, EU Orphan Drug Designations (ODD), EU & UK Pediatric Investigation Plans (PIP), Scientific Advices, EU and UK Variations • Supporting clients on their EU and US regulatory activities and Strategic aspects • Preparing regulatory submissions including Pre-MA procedures, INDs, BLAs, NDAs, MAAs, variations, renewals and MA Transfers • Manage and maintain IRIS, CTIS, IRAS and MHRA portal submissions

Reviewed published reports/biomedical literature to ascertain if they contain a case report of an adverse reaction Wrote accurate and concise summaries that captured the key elements from published adverse drug reaction case reports in Reactions Weekly (Springer publications) Ensured consistent coding of medical history, drugs and adverse event terms (MedDRA)

Regulatory Affairs and Clinical Trial Management, Intellectual Property Management and Contract Laws, Human Resources Management and Strategic Marketing in Life Sciences, Corporate Finance and New Technologies and Business Administration