Dr. rer. nat. Sandra Werner-Monnheimer, M.Sc. Regulatory Affairs, TÜV certified Material Compliance Manager
- Several years of experience in the field of marketing authorisation of finished medicinal products
- Implementation of several registration procedures for generics
- Experience in the field of API manufacturing including DMF preparation and CEPs
- Experience in regulatory affairs for medical devices class IIa, IIb, III, CE area, USA, ROW
- Experience in postmarketing set-up according to MDR
- Material compliance