Skills

  • Healthcare

Experience

Mariangela Marozza

Work experience
  • Executive Director Regulatory Affairs at   Organon
  • Regulatory Affairs Director of multinational pharmaceutical companies, with approximately 40 years of experience in national (Italian) and regional (European) role; strong expertise in:
  •  Development and execution of regulatory strategies for registering and maintaining the marketing authorization of pharma products (small and large molecules; biologicals; generics; biosimilars) of most therapeutic areas, within the geographic European Region, through EU procedures
  •  CTA according to the EU CT Regulation; EAP
  •  Interactions with Local and Regional Regulatory Authorities
  •  Regulatory due diligence review of business deals (licencing in/out)
  •  Registration and introduction on the market of medical devices, food supplements, cosmetics, in compliance with the respective EU regulations.
  •  Scientific Service, Advertising, Regulatory training, Pharmacovigilance

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