13 Jahre Senior Consultant RA

10 Jahre Head of RA (hands on)

Informationsbeauftragter (gemäß §74a Arzneimittelgesetz)

Sachverständiger für Abgrenzung Arzneimittel / Lebensmittel, Nahrungsergänzungsmittel und bilanzierte Diäten

OTC-drugs, food supplements, enriched and dietetic food:
Regulatory safeguarding of existing products and extension of the product portfolio
Maintaining and improving regulatory compliance
Marketability and compliance assessments
Lifecycle Management; Product notifications, authorizations und variations
Regulatory support and advice for the cross-functional teams, e.g. product development, marketing claims
Coordinating regulatory affairs topics with manufacturing sites and cross-functional counterparts in local organizations
Management of HCP or patient queries and complaints
Preparing reports and ensuring regulatory and scientific support for QPPV and the Information Officer
Maintaining, enforcing and improving the QA system
Managing authority relations
Team leader with personnel responsibility

Microsoft Office (Word, Excel, PowerPoint, Access, Outlook)
docuBridge (Lorenz)
eCTDmanager (Extedo)