Regulatory Affairs Specialist with wide experience in maintenance of marketing authorizations with both national and European procedures (variations, renewal and new applications). Interactions with Medicinal Agencies like MHRA, EMA and AIFA. Good knowledge in quality compliance with EU guidelines, regulations and national requirements. Experience in registration process and in launching of new products on the market. Experience in local price and reimbursement procedures. Experience in trasparency and ethics&compliance assessments. Main theraoeutic areas manages. oncoloy, endorinology, neurology.
Short but intense experience in CTA and amendments for biological medicinal products. Regulatory assessment of promotional materials. Support to the Pharmacovigilance on monitoring adverse events. Trainer activity towards the sales force about regulatory aspects focused on products and legislative support to business functions. Represents the company during meetings with customers, pharmaceutical industry association and Authorities. Experience in driving internal or external Audit both for quality and ethics &Compliance activities.