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Regulatory Affairs CMC (Chemistry; Manufacturing; Controls)
Head RA
Head QA
Produkt Entwicklung Pharma & Medical Devices
Englisch
Verhandlungssicher
Französisch
Fortgeschritten
Deutsch
Muttersprache

Einsatzorte

Einsatzorte

Wien (+500km) München (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

5 Jahre
2021-01 - 2025-12

Introduction and Maintenance of Pharmacovigilance and Regulatory Gx Life Cycle Management System

Head Regulatory Affairs & Information Officer SPOR DMS DB SAP
Head Regulatory Affairs & Information Officer
  • Management of the regional regulatory team
  • New MAAs and life cycle management of 630 Gx product licenses
  • Introduction of a GMP compliant regulatory compliance system
  • GDP compliant Management of all CMC, Product Information and Artwork related Processes of the German Affiliate Heumann Pharma
  • Introduction and Management of an IDMP based Regulatory Information and Submission Management System
  • Management of Safety Relevant Actions & Artwork
630 Generics
SPOR DMS DB SAP
TORRENT PHARMA Nürnberg, Deutschland
Nürnberg
3 Jahre 5 Monate
2017-09 - 2021-01

Global Regulatory CMC Management Biotec

Director R&D Regulatory Affairs CMC (Consultant)
Director R&D Regulatory Affairs CMC (Consultant)
  • 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.
SHIRE PLASMA DERIVED THERAPIES R&D Vienna, Austria
1 Jahr 2 Monate
2016-08 - 2017-09

Establishment of a Gx Startup

Head Quality and Regulatory Affairs; Pharmaceutical Responsible Person (Consultant)
Head Quality and Regulatory Affairs; Pharmaceutical Responsible Person (Consultant)
  • EU expansion of a portfolio of oncological Gx drugs: 7 decentralized procedures, 8 variations
  • Establishment of a GxP compliance system with successful EU GMP inspection in January 2017 (3 minors)
  • License of 2 manufacturing processes and sites from India in Europe
  • Establishment of a GVP compliant pharmacovigilance system
  • Pharmaceutical and Pharmacovigilance responsible person for drugs, QPPV and Deputy QPPV
START UP SHILPA MEDICARE EUROPE GMBH, Vienna, Austria
11 Monate
2015-09 - 2016-07

Global (EU/US) Licensing of Medical Devices and Pharmaceuticals

Head CMC Quality and Regulatory Affairs; Pharmaceutical Responsible Person (Consultant)
Head CMC Quality and Regulatory Affairs; Pharmaceutical Responsible Person (Consultant)
  • 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: 30 amendments, 20 variations
  • Pharmaceutical and Pharmacovigilance responsible person for medical devices and pharmaceutical drugs
ALCON OPHTHALMIKA GMBH, Vienna, Austria
1 Jahr 2 Monate
2014-07 - 2015-08

Curving out a global strategic regulatory, quality and pharmacovigilance organization

Head CMC Quality and Regulatory Affairs, QPPV (Consultant)
Head CMC Quality and Regulatory Affairs, QPPV (Consultant)
  • 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 for Anti-Thymocycte Globulin
  • 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
  • Establishment of a global pharmacovigilance and drug safety management process
  • Expert for US Anti-Thymocyte Globulin
  • Transition of 52 licenses and the PV system from Fresenius to Neovii
FRESENIUS BIOTECH/NEOVII BIOTECH, Munich, Germany
2 Jahre 8 Monate
2011-11 - 2014-06

Biosimilar & Device Development

Head Global Regulatory Affairs DIN 13485
Head Global Regulatory Affairs
  • Development of succession molecules for Memantine in Alzheimer
  • 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 license of the Biosimilar Botox 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 modul 3
  • Stabilization of the existing Merz 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
Xeomin
DIN 13485
MERZ PHARMACEUTICALS GMBH, Frankfurt, Germany
4 Jahre 4 Monate
2007-07 - 2011-10

Management of the regional regulatory and quality assurance organization

Regional Director Regulatory Affairs and Quality Assurance; Pharmaceutical Responsible Person
Regional Director Regulatory Affairs and Quality Assurance; Pharmaceutical Responsible Person
  • 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 CEECIS
  • 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
  • Manufacturing and process development of Prevenar 13v, CTA/IND and successful centralized procedure
  • Establishment of a matrix organization of country and product experts for the region Austria & CEE/CIS
  • Expansion of the Wyeth Portfolio to CIS, Russia, Ukraine and the Balkan
  • Regional implementation of the "Clinical Trial Applications" process
  • Regional implementation and enhancement of Wyeth GXP and GMP Quality System Elements in 14 CEE/CIS countries including Russia: transfer of cGMP QSE elements to CIS
  • Development and maintenance of an East European "Key Opinion Leader" network
WYETH PHARMA (A PFIZER COMPANY), Vienna, Austria
1 Jahr 3 Monate
2006-04 - 2007-06

Management of global phase I to III development projects

Global Regulatory Project Leader
Global Regulatory Project Leader
  • Management of global phase I to III development projects with international project teams and representation of Global DRA at Novartis management board: 1 PIP, 1 CP and CIS/ASIA expansion (Lucentis)
  • Expert for Visudyne, Lucentis (Wet Macula Degeneration), Rebamipide (Glaucoma) and Genteal (Eye Drops)
  • Manufacturing process development of Rebamipide for conducting clinical trials
  • Establishment of an ISO 13485 based quality system for the manufacture of medical devices
  • License of a Class 2b Device (Eye Drop/Artificial Tear) in Europe and US
  • Definition of the global Biologics and Rx regulatory development plan in new drug development in the therapeutic area Dry Eye through 10 national scientific advice procedures
  • Design and implementation of EU health authority lobbying strategy with the "Regulatory Review Board"
  • Leadership of the European DRA team
  • Scientific advice procedures with EMEA & FDA
NOVARTIS PHARMA, Basel, Switzerland
4 Jahre 6 Monate
2001-10 - 2006-03

Batch registration for the QP of the polyclonal antibody portfolio

Associate Director European Regulatory Affairs Comparability Protocol
Associate Director European Regulatory Affairs
  • Batch registration for the QP of the polyclonal antibody portfolio (OCABRE) in OMCL laboratories in Germany and Austria
  • Development and upscaling of the new immunoglobulin KIOVIG process, Scientific Advice and CTA, final coordination of the global licensing projects for the EU and US: 1 CP, 1 NDA
  • Development and licensing support of Abumin-free Recombinate and Advate
  • Compliance & life cycle management: >200 CMC variations
  • Building of a new team and change management
  • Global Strategic portfolio management
  • Expert for the immunoglobulins KIOVIG, Gammagard, Subcuvia, Tetanoglobulin and Partobulin.
  • Expert for serum free recombinant Factor VIII: 1 MAA
  • Expert for Cyclophosphamide, Ifosphamide and Mesna: 3 MRPs
  • Module 3 compliance management of the European antibody portfolio with the manufacturing plants of Baxter Bioscience
  • European MRP licenses for the Immunoglobulins Subcuvia, Partobulin and Tetaglobulin
  • Global development and first US and European license for next generation IGIV (KIOVIG)
  • Reorganization of the Oncology team
  • Creation of regulatory processes for renewals, dossier creation, change control, and license procedures
  • Successful EU Gx procedures in Anesthesiology (Sevofluran Baxter) and Oncology (Ifosphamide Baxter)
Next Generation IgIVs
Comparability Protocol
BAXTER BIOSCIENCE
Wien
1 Jahr 3 Monate
2000-07 - 2001-09

Team management and coordination of global life cycle & licensing projects

Group Leader Critical Care in European Regulatory Affairs Nachzulassung
Group Leader Critical Care in European Regulatory Affairs
  • Team management and coordination of global life cycle & licensing projects
  • Expert for Antithrombin III (Kybernin), Haemocompletan (Fibrinogen), Berinert (C-Esterase Inhibitor) and Albumin
  • CMC compliance management of the critical care portfolio in 3 plants through new modul 3
  • European mutual recognition procedure and regulatory life cycle management of C1-Esterase Inhibitor, Fibrinogen, Antithrombin III and Prothrombin Complex
  • Establishment of the Plasma Master File based on a GMP quality system for Plasma collection
Critcal Care Blood Products
Nachzulassung
AVENTIS BEHRING
Marburg / Lahn
4 Jahre
1996-07 - 2000-06

Regulatory & clinical project management

Project Manager Regulatory and Clinical Affairs
Project Manager Regulatory and Clinical Affairs
  • Regulatory & clinical project management in Europe and Japan
  • Expert in Oncology for Bleomycin, Etoposide, Cisplatinum, and Pirarubicin, in Rheumatology for Spanidin
  • CADREAC member states and national European licenses for Etoposide, Bleomycin, Cisplatinum and oral Ara C
  • Phase II/III clinical trial data leading to a patent for treatment of autoimmune diseases with 15-deoxyspergualin
  • Establishment of EU GMP in Takasaki plant in Japan
  • Creation of the global regulatory dossier for 15-deoxyspergualin with Japanese pharmaceutical data (Nippon Kayaku), European Toxicological Data (Behringwerke) and US American Clinical Data (Bristol Myers Squipp)
  • Orphan drug status for 15-Deoxyspergualin in Europe
  • Successful GCP Inspection
  • List B status at the EMEA and successful centralised procedure
EURO NIPPON KAYAKU GMBH
1 Jahr 1 Monat
1995-06 - 1996-06

Sales Representative

  • Management of a sales budget of 25 million DM
  • Establishment of phase IV clinical studies in high dose chemotherapy of solid tumors
  • Expert for Neupogen and Filgrastim
  • Establishment of high dose chemotherapy groups in South Germany
  • 30% growth of the regional sales
AMGEN GMBH, Munich, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

09/1991

Diploma in Immunology, Genetics, Neurology and Biochemistry (excellent)


02/1995

Doctor rerum naturum (magna cum laude) in Tumor-Immunology


07/2017

Graduate course pharmaceutical quality management, Faculty of Pharmacy

Post Graduate pharmaceutical quality management (grade 2)

University of Vienna

Position

Position

Interim Head RA&QA, CMC Regulatory Affairs, Information Officer, Graduated Plan Officer

Kompetenzen

Kompetenzen

Top-Skills

Regulatory Affairs CMC (Chemistry; Manufacturing; Controls) Head RA Head QA Produkt Entwicklung Pharma & Medical Devices

Produkte / Standards / Erfahrungen / Methoden

Management RAQA
Experte
RA CMC Biologics
Experte
Stufenplan Beauftragter
Experte

SUMMARY

  • PhD in Immunology, Post graduate PharmD
  • Head Regulatory Affairs DACH; Pharmaceutical Responsible Person Rx & Devices; Information Officer; Local QPPV
  • Director R&D Regulatory Affairs CMC Biologics Shire
  • Regional Director RAQA Pfizer
  • Scientist with Experience in CMC Development and Manufacturing of Biologics, Small Molecules and Devices;
  • Management of CMC & RAQA teams 7/30 employees
  • Regulatory Life Cycle Management Europe & World-Wide Marketing Authorizations of Manufacturing Processes, Plants and Products from devices to small molecules and Biologics
  • Experience in Global Development and new Marketing Authorizations in Oncology ? Rheumatology ? Nephrology ? Hematology ? Ophthalmology ? Neurology ? Aesthetics ? Biosimilars ? Generics



Regulatory Affairs

Investigational Medicinal Product Dossier/IND
Experte
Scientific Advice
Experte
Type C Meetings
Experte
Manufacturing Process Development
Experte
Module 3
Experte
Quality by Design
Experte
Comparability Protocol
Experte
Site Master File
Experte
Drug Master File
Experte
CMC Life Cycle Management
Experte
Active Substance Master File
Experte
Tech Transfer
Experte
QC Site Transfer
Experte
Real Time Release
Experte
Network Stream Projects
Experte
Product Development
Experte
CMC Inspections
Experte
Change Control
Experte
Product Management System
Experte
Artwork & Labelling
Experte
Authority Management
Experte
Team Management
Experte

Managementerfahrung in Unternehmen

Reorganization
Experte
Team Management
Experte

Branchen

Branchen

Biotec, Pharma, Medical Devices, Research & Development

Einsatzorte

Einsatzorte

Wien (+500km) München (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

5 Jahre
2021-01 - 2025-12

Introduction and Maintenance of Pharmacovigilance and Regulatory Gx Life Cycle Management System

Head Regulatory Affairs & Information Officer SPOR DMS DB SAP
Head Regulatory Affairs & Information Officer
  • Management of the regional regulatory team
  • New MAAs and life cycle management of 630 Gx product licenses
  • Introduction of a GMP compliant regulatory compliance system
  • GDP compliant Management of all CMC, Product Information and Artwork related Processes of the German Affiliate Heumann Pharma
  • Introduction and Management of an IDMP based Regulatory Information and Submission Management System
  • Management of Safety Relevant Actions & Artwork
630 Generics
SPOR DMS DB SAP
TORRENT PHARMA Nürnberg, Deutschland
Nürnberg
3 Jahre 5 Monate
2017-09 - 2021-01

Global Regulatory CMC Management Biotec

Director R&D Regulatory Affairs CMC (Consultant)
Director R&D Regulatory Affairs CMC (Consultant)
  • 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.
SHIRE PLASMA DERIVED THERAPIES R&D Vienna, Austria
1 Jahr 2 Monate
2016-08 - 2017-09

Establishment of a Gx Startup

Head Quality and Regulatory Affairs; Pharmaceutical Responsible Person (Consultant)
Head Quality and Regulatory Affairs; Pharmaceutical Responsible Person (Consultant)
  • EU expansion of a portfolio of oncological Gx drugs: 7 decentralized procedures, 8 variations
  • Establishment of a GxP compliance system with successful EU GMP inspection in January 2017 (3 minors)
  • License of 2 manufacturing processes and sites from India in Europe
  • Establishment of a GVP compliant pharmacovigilance system
  • Pharmaceutical and Pharmacovigilance responsible person for drugs, QPPV and Deputy QPPV
START UP SHILPA MEDICARE EUROPE GMBH, Vienna, Austria
11 Monate
2015-09 - 2016-07

Global (EU/US) Licensing of Medical Devices and Pharmaceuticals

Head CMC Quality and Regulatory Affairs; Pharmaceutical Responsible Person (Consultant)
Head CMC Quality and Regulatory Affairs; Pharmaceutical Responsible Person (Consultant)
  • 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: 30 amendments, 20 variations
  • Pharmaceutical and Pharmacovigilance responsible person for medical devices and pharmaceutical drugs
ALCON OPHTHALMIKA GMBH, Vienna, Austria
1 Jahr 2 Monate
2014-07 - 2015-08

Curving out a global strategic regulatory, quality and pharmacovigilance organization

Head CMC Quality and Regulatory Affairs, QPPV (Consultant)
Head CMC Quality and Regulatory Affairs, QPPV (Consultant)
  • 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 for Anti-Thymocycte Globulin
  • 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
  • Establishment of a global pharmacovigilance and drug safety management process
  • Expert for US Anti-Thymocyte Globulin
  • Transition of 52 licenses and the PV system from Fresenius to Neovii
FRESENIUS BIOTECH/NEOVII BIOTECH, Munich, Germany
2 Jahre 8 Monate
2011-11 - 2014-06

Biosimilar & Device Development

Head Global Regulatory Affairs DIN 13485
Head Global Regulatory Affairs
  • Development of succession molecules for Memantine in Alzheimer
  • 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 license of the Biosimilar Botox 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 modul 3
  • Stabilization of the existing Merz 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
Xeomin
DIN 13485
MERZ PHARMACEUTICALS GMBH, Frankfurt, Germany
4 Jahre 4 Monate
2007-07 - 2011-10

Management of the regional regulatory and quality assurance organization

Regional Director Regulatory Affairs and Quality Assurance; Pharmaceutical Responsible Person
Regional Director Regulatory Affairs and Quality Assurance; Pharmaceutical Responsible Person
  • 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 CEECIS
  • 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
  • Manufacturing and process development of Prevenar 13v, CTA/IND and successful centralized procedure
  • Establishment of a matrix organization of country and product experts for the region Austria & CEE/CIS
  • Expansion of the Wyeth Portfolio to CIS, Russia, Ukraine and the Balkan
  • Regional implementation of the "Clinical Trial Applications" process
  • Regional implementation and enhancement of Wyeth GXP and GMP Quality System Elements in 14 CEE/CIS countries including Russia: transfer of cGMP QSE elements to CIS
  • Development and maintenance of an East European "Key Opinion Leader" network
WYETH PHARMA (A PFIZER COMPANY), Vienna, Austria
1 Jahr 3 Monate
2006-04 - 2007-06

Management of global phase I to III development projects

Global Regulatory Project Leader
Global Regulatory Project Leader
  • Management of global phase I to III development projects with international project teams and representation of Global DRA at Novartis management board: 1 PIP, 1 CP and CIS/ASIA expansion (Lucentis)
  • Expert for Visudyne, Lucentis (Wet Macula Degeneration), Rebamipide (Glaucoma) and Genteal (Eye Drops)
  • Manufacturing process development of Rebamipide for conducting clinical trials
  • Establishment of an ISO 13485 based quality system for the manufacture of medical devices
  • License of a Class 2b Device (Eye Drop/Artificial Tear) in Europe and US
  • Definition of the global Biologics and Rx regulatory development plan in new drug development in the therapeutic area Dry Eye through 10 national scientific advice procedures
  • Design and implementation of EU health authority lobbying strategy with the "Regulatory Review Board"
  • Leadership of the European DRA team
  • Scientific advice procedures with EMEA & FDA
NOVARTIS PHARMA, Basel, Switzerland
4 Jahre 6 Monate
2001-10 - 2006-03

Batch registration for the QP of the polyclonal antibody portfolio

Associate Director European Regulatory Affairs Comparability Protocol
Associate Director European Regulatory Affairs
  • Batch registration for the QP of the polyclonal antibody portfolio (OCABRE) in OMCL laboratories in Germany and Austria
  • Development and upscaling of the new immunoglobulin KIOVIG process, Scientific Advice and CTA, final coordination of the global licensing projects for the EU and US: 1 CP, 1 NDA
  • Development and licensing support of Abumin-free Recombinate and Advate
  • Compliance & life cycle management: >200 CMC variations
  • Building of a new team and change management
  • Global Strategic portfolio management
  • Expert for the immunoglobulins KIOVIG, Gammagard, Subcuvia, Tetanoglobulin and Partobulin.
  • Expert for serum free recombinant Factor VIII: 1 MAA
  • Expert for Cyclophosphamide, Ifosphamide and Mesna: 3 MRPs
  • Module 3 compliance management of the European antibody portfolio with the manufacturing plants of Baxter Bioscience
  • European MRP licenses for the Immunoglobulins Subcuvia, Partobulin and Tetaglobulin
  • Global development and first US and European license for next generation IGIV (KIOVIG)
  • Reorganization of the Oncology team
  • Creation of regulatory processes for renewals, dossier creation, change control, and license procedures
  • Successful EU Gx procedures in Anesthesiology (Sevofluran Baxter) and Oncology (Ifosphamide Baxter)
Next Generation IgIVs
Comparability Protocol
BAXTER BIOSCIENCE
Wien
1 Jahr 3 Monate
2000-07 - 2001-09

Team management and coordination of global life cycle & licensing projects

Group Leader Critical Care in European Regulatory Affairs Nachzulassung
Group Leader Critical Care in European Regulatory Affairs
  • Team management and coordination of global life cycle & licensing projects
  • Expert for Antithrombin III (Kybernin), Haemocompletan (Fibrinogen), Berinert (C-Esterase Inhibitor) and Albumin
  • CMC compliance management of the critical care portfolio in 3 plants through new modul 3
  • European mutual recognition procedure and regulatory life cycle management of C1-Esterase Inhibitor, Fibrinogen, Antithrombin III and Prothrombin Complex
  • Establishment of the Plasma Master File based on a GMP quality system for Plasma collection
Critcal Care Blood Products
Nachzulassung
AVENTIS BEHRING
Marburg / Lahn
4 Jahre
1996-07 - 2000-06

Regulatory & clinical project management

Project Manager Regulatory and Clinical Affairs
Project Manager Regulatory and Clinical Affairs
  • Regulatory & clinical project management in Europe and Japan
  • Expert in Oncology for Bleomycin, Etoposide, Cisplatinum, and Pirarubicin, in Rheumatology for Spanidin
  • CADREAC member states and national European licenses for Etoposide, Bleomycin, Cisplatinum and oral Ara C
  • Phase II/III clinical trial data leading to a patent for treatment of autoimmune diseases with 15-deoxyspergualin
  • Establishment of EU GMP in Takasaki plant in Japan
  • Creation of the global regulatory dossier for 15-deoxyspergualin with Japanese pharmaceutical data (Nippon Kayaku), European Toxicological Data (Behringwerke) and US American Clinical Data (Bristol Myers Squipp)
  • Orphan drug status for 15-Deoxyspergualin in Europe
  • Successful GCP Inspection
  • List B status at the EMEA and successful centralised procedure
EURO NIPPON KAYAKU GMBH
1 Jahr 1 Monat
1995-06 - 1996-06

Sales Representative

  • Management of a sales budget of 25 million DM
  • Establishment of phase IV clinical studies in high dose chemotherapy of solid tumors
  • Expert for Neupogen and Filgrastim
  • Establishment of high dose chemotherapy groups in South Germany
  • 30% growth of the regional sales
AMGEN GMBH, Munich, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

09/1991

Diploma in Immunology, Genetics, Neurology and Biochemistry (excellent)


02/1995

Doctor rerum naturum (magna cum laude) in Tumor-Immunology


07/2017

Graduate course pharmaceutical quality management, Faculty of Pharmacy

Post Graduate pharmaceutical quality management (grade 2)

University of Vienna

Position

Position

Interim Head RA&QA, CMC Regulatory Affairs, Information Officer, Graduated Plan Officer

Kompetenzen

Kompetenzen

Top-Skills

Regulatory Affairs CMC (Chemistry; Manufacturing; Controls) Head RA Head QA Produkt Entwicklung Pharma & Medical Devices

Produkte / Standards / Erfahrungen / Methoden

Management RAQA
Experte
RA CMC Biologics
Experte
Stufenplan Beauftragter
Experte

SUMMARY

  • PhD in Immunology, Post graduate PharmD
  • Head Regulatory Affairs DACH; Pharmaceutical Responsible Person Rx & Devices; Information Officer; Local QPPV
  • Director R&D Regulatory Affairs CMC Biologics Shire
  • Regional Director RAQA Pfizer
  • Scientist with Experience in CMC Development and Manufacturing of Biologics, Small Molecules and Devices;
  • Management of CMC & RAQA teams 7/30 employees
  • Regulatory Life Cycle Management Europe & World-Wide Marketing Authorizations of Manufacturing Processes, Plants and Products from devices to small molecules and Biologics
  • Experience in Global Development and new Marketing Authorizations in Oncology ? Rheumatology ? Nephrology ? Hematology ? Ophthalmology ? Neurology ? Aesthetics ? Biosimilars ? Generics



Regulatory Affairs

Investigational Medicinal Product Dossier/IND
Experte
Scientific Advice
Experte
Type C Meetings
Experte
Manufacturing Process Development
Experte
Module 3
Experte
Quality by Design
Experte
Comparability Protocol
Experte
Site Master File
Experte
Drug Master File
Experte
CMC Life Cycle Management
Experte
Active Substance Master File
Experte
Tech Transfer
Experte
QC Site Transfer
Experte
Real Time Release
Experte
Network Stream Projects
Experte
Product Development
Experte
CMC Inspections
Experte
Change Control
Experte
Product Management System
Experte
Artwork & Labelling
Experte
Authority Management
Experte
Team Management
Experte

Managementerfahrung in Unternehmen

Reorganization
Experte
Team Management
Experte

Branchen

Branchen

Biotec, Pharma, Medical Devices, Research & Development

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