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Regulatory Affairs CMC (Chemistry; Manufacturing; Controls)
Lifecycle Management RAQA
Pharmacovigilance
Interim Management in RAQAPV
Introduction and Validation of Computerized Systems in RAQAPV

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 Manager RAQAPV

Kompetenzen

Kompetenzen

Top-Skills

Regulatory Affairs CMC (Chemistry; Manufacturing; Controls) Lifecycle Management RAQA Pharmacovigilance Interim Management in RAQAPV Introduction and Validation of Computerized Systems in RAQAPV

Produkte / Standards / Erfahrungen / Methoden

SUMMARY

  • PhD in Immunology, Post graduate PharmD
  • Consultant: Head Regulatory Affairs & CMC; Pharmaceutical Responsible Person Rx & Devices; Information Officer; QPPV
  • 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


Key Words:

  • Information Officer 
  • QPPV 
  • Pharmaceutical Responsible Person - Clinical Trial Applications 
  • INDs - IMPD 
  • RMP 
  • Scientific Advice 
  • Type C Meetings - Manufacturing Process Development - CMC Life Cycle Management 
  • ASMF 
  • DMF 
  • Module 3 
  • Quality by Design 
  • Tech Transfers 
  • QC Site Transfers 
  • Comparability Protocol 
  • Real Time Release 
  • Network Stream CMC Projects 
  • cGMP Quality System Elements 
  • Medicinal Products 
  • API 
  • Formulation 
  • Biologics - ISO 13485 Devices 
  • Combination Products - Audits 
  • CMC Inspections 
  • Validation 
  • Manufacturing 
  • CAPA 
  • Change Control 
  • IDMP 
  • Regulatory Information Management Systems


Experience

Role: Pharmaceutical responsible person

Customer: Torrent Pharma Germany


2011

Role: Pharmaceutical Responsible Person, Gewerberechtlicher Geschäftsführer

Customer: on request


2015

Role: Pharmaceutical Responsible Person, Gewerberechtlicher Geschäftsführer

Customer: on request


2021

Role: Pharmaceutical Responsible Person, Gewerberechtlicher Geschäftsführer

Customer: on request


09/1990 ? 06/1995

Role: Doctor of Life Sciences Student

Customer: Institute of Cellular Immunology and Genetics, German Cancer Research Center; Heidelberg, Germany

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 Manager RAQAPV

Kompetenzen

Kompetenzen

Top-Skills

Regulatory Affairs CMC (Chemistry; Manufacturing; Controls) Lifecycle Management RAQA Pharmacovigilance Interim Management in RAQAPV Introduction and Validation of Computerized Systems in RAQAPV

Produkte / Standards / Erfahrungen / Methoden

SUMMARY

  • PhD in Immunology, Post graduate PharmD
  • Consultant: Head Regulatory Affairs & CMC; Pharmaceutical Responsible Person Rx & Devices; Information Officer; QPPV
  • 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


Key Words:

  • Information Officer 
  • QPPV 
  • Pharmaceutical Responsible Person - Clinical Trial Applications 
  • INDs - IMPD 
  • RMP 
  • Scientific Advice 
  • Type C Meetings - Manufacturing Process Development - CMC Life Cycle Management 
  • ASMF 
  • DMF 
  • Module 3 
  • Quality by Design 
  • Tech Transfers 
  • QC Site Transfers 
  • Comparability Protocol 
  • Real Time Release 
  • Network Stream CMC Projects 
  • cGMP Quality System Elements 
  • Medicinal Products 
  • API 
  • Formulation 
  • Biologics - ISO 13485 Devices 
  • Combination Products - Audits 
  • CMC Inspections 
  • Validation 
  • Manufacturing 
  • CAPA 
  • Change Control 
  • IDMP 
  • Regulatory Information Management Systems


Experience

Role: Pharmaceutical responsible person

Customer: Torrent Pharma Germany


2011

Role: Pharmaceutical Responsible Person, Gewerberechtlicher Geschäftsführer

Customer: on request


2015

Role: Pharmaceutical Responsible Person, Gewerberechtlicher Geschäftsführer

Customer: on request


2021

Role: Pharmaceutical Responsible Person, Gewerberechtlicher Geschäftsführer

Customer: on request


09/1990 ? 06/1995

Role: Doctor of Life Sciences Student

Customer: Institute of Cellular Immunology and Genetics, German Cancer Research Center; Heidelberg, Germany

Branchen

Branchen

Biotec, Pharma, Medical Devices, Research & Development

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