Regulatory Affairs & Information Officer

Over 25 years of global experience in Regulatory Affairs, CMC, Quality and Safety functions — from development through commercialization — across Biologics, Small Molecules and Medical Devices

Successfully managed interactions with EMA, FDA, PMDA, CFDA and numerous national authorities; consistently achieved positive inspection outcomes (GMP, GDP, GVP)

Demonstrated success in transforming complex matrix organizations into efficient, compliant and agile teams — driving faster submissions, reduced costs and operational excellence

Combines scientific depth (PhD in Tumor Immunology) with hands-on regulatory and CMC expertise to enable innovative product development and market access for both emerging biotech and established pharma companies

Network Strategy Lead CMC worldwide manufacturing

CMC strategy lead for global Biologics manufacturing expansion and QC site rationalization

Global Compliance, Life Cycle and Development Management CMC with global authorities EMA, FDA, CFDA, PMDA etc.

Global (EU/US) Licensing of Medical Devices and Pharmaceuticals in eye care: 3 MAAs

Restructure of the quality systems and successful GMP inspections/audits with one minor finding

License & Price management of a portfolio of eye drops

Life cycle management of a portfolio of 300 medical devices and 35 drugs: ca. 30 amendments, ca. 20 variations

Pharmaceutical and Pharmacovigilance responsible person for medical devices and pharmaceutical drugs

Curving out a global strategic regulatory, quality and pharmacovigilance organization and a Biologics producing plant into a mid-sized company

Establishment of an FDA GMP strategy

Development of an FDA compliant manufacturing site and process for an orphan Biologic

Global product license life cycle management (EU, MEA, ASIA, South America): 50 variations

Successful maintenance of the European GMP license

QPPV and establishment of a global pharmacovigilance and drug safety management process

Transition of about 50 licenses and the PV system

Development of succession molecules

Establishment of a global strategic regulatory organization for Biologics, CNS, OTC and Medical Devices

Global life cycle management and license expansion: 4 MAAs, 50 variations

Global product development Biologics, CNS, medical devices and food supplements: 2 MAAs Biosimilars, 3 scientific advices, 6 new medical devices

Manufacturing site and process development, further licensing in the US and Europe

Increase in productivity through reorganization of the regulatory team into a matrix structure of country and product strategy responsibilities

Expansion of the Biosimilar, Rx, OTC and Medical Device portfolio to APAC, LATAM and CIS: 8 global MAAs, 2 global PIP procedures

CMC and GMP expansion to the emerging markets for Biologics and class III/drug combinations: 2 SMFs and new module 3

Stabilization of the existing portfolio through efficient CMC and life cycle management of the established portfolio of Biologics, Rx, OTC and class III medical device products: 60 global compliance variations

Established Products, Emerging markets Europe, Commonwealth of Independent States, Latin America, Asia, Africa & Middle East

Building a global strategic regulatory organization for established products and generics

Life cycle management and license expansion to the emerging markets in over 60 markets with a portfolio of 100+ generics and established products

Expert for emerging markets CMC Gx- and development

Establishment of a Gx country strategy team

Global expansion and CMC compliance management of the generics and established products portfolio

Management of the regional regulatory and quality assurance organization based in Austria, Central & Eastern Europe and Commonwealth of Independent States

Regional therapeutic license portfolio expansion: 300 MAAs and variations in CEE/CIS

Regional CMC compliance management: 200 CMC variations

Management of the regional regulatory and quality assurance organization based in Austria, Central & Eastern Europe and Commonwealth of Independent States

Responsible regional pharmaceutical person