Experience

Regulatory Pharma Net srl

• Regulatory Affairs consultant

  • Mar 2009 - Present

  Consultant for pharmaceutical companies. Regulatory input for development phase I, II and III Identification of registration strategies for new products EMEA and FDA Orphan designations, Scientific Advice and Protocol Assistance CMC IMPD writer Preparation and submission of clinical trial applications and subsequent amendments to the competent authorities and to the Ethics Committees and check progression of the applications until approval Planning and follow-up at central level of National, Mutual Recognition, Decentralised and Centralised Procedures for new Marketing Authorisations, Variations and Renewals (for New Chemical Entities and for products of well-established use) Pharmacovigilance support in Italy including daily check of the Italian PV database (RNF) for each client and transmission of any ICSR to the concerned company. Regulatory due diligence for potential in-licensing products at any stage of the development. Ensuring consistency, completeness, accuracy and adherence to regulations and applicable guidelines for all regulatory submissions. Providing information and advice on registration procedures, international health authority requirements and decision probabilities as well as interpreting world wide regulatory laws, regulations and guidelines. Identifying and communicating potential risks in submissions and anticipate regulatory responses through scenario planning. Building and maintaining professional contacts with scientific experts as well as with national and international authorities. Project Management Show less



Grifols

• Spain
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs and Logistic

  • Sep 2008 - Mar 2009

  Management of regulatory affairs activities and logistic (distribution) for plasma-derived medicinal products. Management of regulatory affairs activities and logistic (distribution) for plasma-derived medicinal products.



MENARINI Group

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Head, Central Regulatory Affairs

  • Jan 2004 - Aug 2008

  Responsible for Menarini Group regulatory activities for registered and under development products.Coordination of the Italian and foreign branches.Responsible of a team of 15 people in the headquarter of the company.Responsible for regulatory due-diligence of products for in-licence.

• Regulatory Affairs Manager

  • Jul 1996 - Dec 2003

  Management of regulatory procedures in European and Extra-european countries.Responsible of the International Regulatory Affairs team.