Global Pharmaceutical Regulatory Affairs Summit is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa

Ana Silvia Nita
Director Regulatory Affairs CMC Biologics at MSD BioPharma, Switzerland

Profile

She was born in Bucharest, Romania where she graduated a bachelor study in Biochemistry.

She did her PhD in Molecular Biology, at Max Planck Institute in Potsdam, Germany.

After few more years working in Molecular Biology research field at Cologne Center for Genomics, Germany, Silvia started her career in Regulatory Affairs working at Basic Pharma, in The Netherlands, working on generic products submission.

She changed after 3 years to work for Grunenthal Pharma, a German company, with headquarter in Aachen, as Regulatory Affairs CMC manager to learn more about global regulatory submissions working on small molecules products.  

Along the way, she also worked more than 5 years for Roche Pharma, in Basel, Switzerland, where she focused on global regulatory CMC strategies for marketed products and lead a group within Small Molecule department.

Recently, beginning of 2019, joined MSD Biopharma, to lead regulatory CMC activities for Biologic products and new technology, developed at the MSD site in Lucerne, Switzerland.

Ana Silvia Nita's Network

Agenda Sessions

  • Examining the Product Registration Landscape in Mexico

    ,
  • Panel Session: Latin America Pain Points

    ,