Giulia Filippi Email & Phone Number

Monza, Lombardia, Italia

• In-line growth from Supervisory position - no change in job role (overall experience in the role since May 2021):
• In-depth knowledge of pharma/CDMO processes and business
• Responsible of business evaluation and quotation activities for steriles drug products
• Exceeded target for new business sales 3 years in a row with 99% OTD for issuance
• Manage group of specialists for quotation activities
• Effective partnering with leadership team and senior management to propose best strategy for site new business

Monza E Brianza, Lombardia, Italia

Monza, Lombardia, Italia

• Initiate local quotation activities (technical scope, budgeting, timelines) once site selection has been confirmed.
• Liaise with Legal department to ensure that the correct legal terms and conditions are applied to a given proposal.
• Ensuring deal pricing / margin discussions with Site Leadership.
• Support the Sales team during discussions with Client, understanding ìthe actions needed to progress a given deal towards successful closure.

Monza, Lombardia, Italia

• Formerly IPQ Tecnologie Srl - acquired by EY in 2023.
• Ensure Client satisfaction for the services provided
• Regulatory Affairs Manager and Quality Assurance Manager for multiple pharma and biomedical companies
• Business Development for new opportunities

Lesmo

• Medical Device dossier management according to Directive 93/42/CEE - MDD and EU Regulation 745/2017 - MDR (Classes I-III)
• Quality system management according to ISO 13485
• Internal and external audit management (CE, ISO)

Monza And Brianza Area, Italy

• MEDICAL DEVICES (sterile, injectable Class III and class I)
• Knowledge of fundamental European and Italian regulations, guidelines (ICH, MEDDEV) and GMP about medical devices, drugs and cosmetics and ISO 9001/ISO 13485
• Writing of medical devices technical file (hyaluronic acid dermal fillers, orthopedic viscosupplementation, chemical peeling)
• Medical devices risk assessment and clinical investigations assessment
• Product design rationale drafting
• Documents preparation for extra-UE registration (CTD, PMF, PIAF, cosmetic declarations)

Milan Area, Italy

QSAR studies on a steroid scaffold for the improvement of a cardiac drug

Milano

Molecular Structure and Interactions course, General and Inorganic Chemistry laboratory, Bioinformatics seminars for Erasmus students

Specialization Course, Management Of Medical Devices And Cosmetics: Regulatory Aspects

High Professional Training In Regulatory Affairs, Affari Regolatori

Doctor Of Philosophy (Ph.D.), Industrial Biotechnology

Activities and Societies: Professional Development for Young Scientists Course

Master Degree In Industrial Biotechnology, Pharmacogenomics, 110/110 Cum Laude

Bachelor Degree In Biotechnology, Molecular Biotechnology, 110/110

Education record