Regulatory Affairs Manager

• Dec 2022 - Present

Regulatory Manger, Global Rare Diseases

• Apr 2021 - Sep 2021

R&D Global Regulatory Affairs Specialist II ATMPs and Biologicals

• Jul 2016 - Apr 2021

Authorized EMA contact regarding regulatory activities and applications • active role as regulatory specialist in two EMA Centralised Procedures for orphan medicinal products assessed as Conditional and Exceptional Circumstances (pre-submission activities, Day 120 LoQ responses, Day 180 LoOI, Linguistic Review Process for Product Information)• responsible and accountable for preparation and management of regulatory submissions (variations, renewals for conditional approved registered products, OD and PIP annual reports);• attendance and contribution to prepare and conduct scientific advice meetings with regulatory agencies (national agencies, FDA, ANVISA) for orphan biotechnological medicinal products • Oversees the planning, implementation, and tracking of both short- and long- term projects and coordinates the establishment and execution of specified deliverables • coordination and preparation of meeting minutes and support in the management of action items to ensure timelines and deliverables are met both in internal meetings involving regulatory function and in interactions with external i.e. service provider• cross-functional team involvement as regulatory representative• manage activities with external service providers• support and authoring in regulatory due diligence and associated report• regulatory lead in submission teams for geographical expansion of biotechnological products (Brazil)

R&D Global Regulatory Affairs ATMP and Biologicals Officer

• Feb 2014 - Jul 2016

- active role in 3 Orphan Drug application submissions for ATMPs in Europe- attendance and contribution to prepare and conduct scientific advice meetings with regulatory agencies (national agencies, FDA, ANVISA) for orphan biotechnological medicinal products - responsible and accountable for preparation and management of regulatory submissions (variations, renewals for conditional approved registered products, OD and PIP annual reports);- cross-functional team involvement as regulatory representative- manage activities with external service providers- support and authoring in regulatory due diligence and associated report

2nd level master

• Feb 2014 - Jan 2016

Internship Trainee

• Nov 2013 - Feb 2014

Internship for Master's thesis

• Feb 2012 - Apr 2013

University Internship Program for Master’s experimental thesis on the activity of soy isoflavones and their metabolites on prostatic cancer cells (Prof. S.Bettuzzi), Department of Biomedical, Biotechnological and Translational Science, University of Parma University Internship Program for Master’s experimental thesis on the activity of soy isoflavones and their metabolites on prostatic cancer cells (Prof. S.Bettuzzi), Department of Biomedical, Biotechnological and Translational Science, University of Parma

Internship as Laboratory operator

• Jun 2010 - Sep 2010

Internship as laboratory operator at Lesaffre Italia S.p.a. , (a leading biotechnological food ingredients company in the production of bread-making yeast and yeast extracts) as control operator for microbiological, chemical and physical tests, where I got trained in quality control . Internship as laboratory operator at Lesaffre Italia S.p.a. , (a leading biotechnological food ingredients company in the production of bread-making yeast and yeast extracts) as control operator for microbiological, chemical and physical tests, where I got trained in quality control .

Internship for Bachelor's thesis

• Oct 2009 - Apr 2010

University Internship Program for Bachelor’s experimental thesis on the quaternary structure of S- allantoin synthase enzyme (Prof. R.Percudani), Department of Biochemistry and Molecular Biology of the University of Parma University Internship Program for Bachelor’s experimental thesis on the quaternary structure of S- allantoin synthase enzyme (Prof. R.Percudani), Department of Biochemistry and Molecular Biology of the University of Parma