Diane De Michelena

About

Experience

• R&D Regulatory Affairs Project Manager at Laboratoires Théa
  Sep 2024 - Present · 1 yr 11 mos

  Global R&D activities EU, USA & Canada PDCO meeting EMA Scientific advice Pre IND & IND Pre NDS meeting

• Regulatory Affairs Manager at Advicenne
  Mar 2022 - Jul 2024 · 2 yrs 5 mos

  SME - Rare disease - EMA centralised procedure Middle East Registration Centralized procedure Life Cycle Management (bluebox, specimen review, PSUR and variations etc)

• Regulatory Affairs Project Manager at Unither Pharmaceuticals
  Feb 2019 - Jan 2022 · 3 yrs

  European Decentralized Procedure Scientific advice - R&D

• International Regulatory Affairs Manager - Oncology at Pierre Fabre Group
  Jan 2018 - Jan 2019 · 1 yr 1 mo

  Consultant Registration in Brazil and Mexico

• Regulatory Affairs Manager - Rare diseases - North Africa zone at Sobi - Swedish Orphan Biovitrum AB (publ)
  Sep 2017 - Dec 2017 · 4 mos

  Consultant Orphan drug - registration in North Africa