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Snr. Director Drug Regulatory Affairs: Principal Consultant & Interim Manager

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  • 56410 Montabaur
  • National
  • de  |  en
  • 11.02.2024

Kurzvorstellung

Dr.rer.nat.; 30 years in pharm. industry, biotech and Competent Authority (assessor at PEI); Global Drug RA Generalist: Pre-authorisation phase, MAAs, Maintenance/LCM; Broad spectrum of therap. areas, DS and DP (M1, 2, 3, 5); Lead positions

Qualifikationen

  • Naturwissenschaft
  • Regulatory Affairs Management

Projekt‐ & Berufserfahrung

Snr. Director/Principal Consultant Drug Regulatory Affairs
H. [...] Consulting, Montabaur
12/2011 – offen (12 Jahre, 4 Monate)
Pharmaindustrie
Tätigkeitszeitraum

12/2011 – offen

Tätigkeitsbeschreibung

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Homepage: H. [...] Consulting and Interim Management
For description of projects and detailed discussion, please contact me:[...]

Eingesetzte Qualifikationen

Regulatory Affairs Management

Director Global RA , Head RA Compliance and Intelligence (Festanstellung)
Micromet GmbH, München
9/2010 – 1/2012 (1 Jahr, 5 Monate)
Pharmaindustrie
Tätigkeitszeitraum

9/2010 – 1/2012

Tätigkeitsbeschreibung

Division: Global Regulatory Affairs

Main achievements:
- Responsible for filing readiness process for lead compound
- Responsible for regulatory strategy
- Responsible for approval of multinational CTAs
- Led RA activities in multidisciplinary teams
- Led RA professional team
- Led SOP implementation
- Enlarged consultant network
- Products: Biotech
- Therapeutic area: Hematooncology

Eingesetzte Qualifikationen

Regulatory Affairs Management

European and Global RA Project Leader
TEVA Innovative, Mörfelden-Walldorf
3/2008 – 8/2010 (2 Jahre, 6 Monate)
Pharmaindustrie
Tätigkeitszeitraum

3/2008 – 8/2010

Tätigkeitsbeschreibung

Division: European Regulatory Affairs

Main achievements:
- Led all EU/European activities for assigned projects
- Received MRP indication extension for one CNS product
- Received orphan designations
- Achieved PIP approvals
- Achieved approval of CTAs
- Conducted Scientific Advice
- Received approval of variations (Type IB, II) and renewals
- Led 29 EU/European subsidiaries
- Products: NCEs, ATMP
- Therapeutic area: CNS, Oncology, Hematoonocology

Eingesetzte Qualifikationen

Regulatory Affairs Management

Senior RA Manager Europe
Otsuka Frankfurt Research Institute, Frankfurt
10/2003 – 2/2008 (4 Jahre, 5 Monate)
Pharmaindustrie
Tätigkeitszeitraum

10/2003 – 2/2008

Tätigkeitsbeschreibung

Division: European Regulatory Affairs

Main achievements:
- Built-up RA division from scratch
- Prepared two CPs
- Achieved approval of extension application for one CP product
- Evaluated early development projects
- Supervised MRP line extensions
- Prepared Otsuka's first CTD
- Supervised eCTD/pCTD process
- Achieved approval of CTAs
- Supervised RA staff
- Built-up consultant network
- Implemented document management system
- Products: NCEs, in vivo diagnostic
- Therapeutic areas: GI, Infectious disease, CNS

Eingesetzte Qualifikationen

Regulatory Affairs Management

Global RA Manager
Merck KGaA, Darmstadt
9/1999 – 9/2003 (4 Jahre, 1 Monat)
Pharmaindustrie
Tätigkeitszeitraum

9/1999 – 9/2003

Tätigkeitsbeschreibung

Division: Global Regulatory Affairs

Main achievements:
- Achieved MA for a CV product
- Achieved approval for CTAs in EU/Europe and South Africa
- Achieved approval for INDs in the US
- Received import license for a biotech product
- Maintained marketing authorizations
- Assessed EPARs
- Conducted cross-functional trainings
- Products: Biotech, NCEs
- Therapeutic areas: Oncology, CNS, CV, Thyroid

Eingesetzte Qualifikationen

Regulatory Affairs Management

Pharmaceutical Assessor
Paul-Ehrlich-Institut, Langen
5/1996 – 8/1999 (3 Jahre, 4 Monate)
Pharmaindustrie
Tätigkeitszeitraum

5/1996 – 8/1999

Tätigkeitsbeschreibung

Division: Hematology and Transfusion medicine

Main achievements:
- Built-up new division at PEI
- Led a specific MAA procedure incl. issuing rejection letter
- Led the laboratory with 9 co-workers
- Developed a method for sterility testing of blood components as a member of the AK Blood at BMG
- Products: Blood
- Therapeutic area: Blood clotting

Sales Representative Diagnostics
Nichols Institute, Norddeutschland
11/1994 – 4/1996 (1 Jahr, 6 Monate)
Diagnostika
Tätigkeitszeitraum

11/1994 – 4/1996

Tätigkeitsbeschreibung

Main achievements:
- Successfully consulted and trouble-shot assay and hard ware failures at clients

Zertifikate

Promotion in life science (Dr.rer.nat.)
1994
Diplom-Chemikerin
1990

Ausbildung

Chemie/Biochemie
Diplom-Chemikerin; Promotion Biochemie
1994
Bonn

Über mich

Homepage: -Hyperlink entfernt-

I’m a Drug Regulatory Affairs Consultant with 29 years’ experience.
As of today, I have been working as a self-employed Principal Consultant for 12 years.
My working style is solution oriented. I am ready to leave he comfort zone.
I am contributing to new aspects and approaches to my different clients, delighted to provide strategic advice and hands-on experience and business support.

During my permanent employments from 1994 until 2012 I have been working for Regulatory Affairs departments at the Paul-Ehrlich-Institute (assessor), global innovative pharmaceutical industry and biotech companies.
There, my main focus was on EU/European and global regulatory procedures with ever increasing responsibilities and leadership of RA and cross-functional teams.

For a Japanese mother company, I set up the EU RA division from scratch including analysis of business processes, specifying user and functional requirements for collaboration with external partners.
For other companies/institutions the business area was to be established (e.g.; PEI) and/or tailored/enlarged (e.g.; Merck).

I am familiar with various therapeutic areas such as Hematology, Neuroscience, Oncology, CV, GI, Thyroid and Infectious diseases as well as the most diverse types of active substances such as small molecules, large molecules (biotech, biosimilar), Blood, ATMP, and in vivo diagnostics, formulated drug products and the diversity of drug administrations and GxP.
I am used to supervise and manage RA and cross-functional teams and cooperate with internal and external stakeholders at global level.

The clients for which I am working as RA lead and representative since 2011 are global pharma players, biotech companies and start-ups, RA consulting firms and national affiliates; in cross-functional teams, too.

In the global context I’m offering to my clients RA strategies, management of drug development, marketing authorizations, maintenance and LCM, RA compliance projects including merger of companies all on the basis of country specific legislation and company specific business requirements.

Weitere Kenntnisse

Education

PhD (Dr.rer.nat) in Biochemistry at the Rheinische-Friedrich-Wilhelms University, Bonn
Chemist (Diplom-Chemikerin) at the Rheinische-Friedrich-Wilhelms University, Bonn

Further skills

Languages: German: Mother tongue
English: Business fluent

Computer literacy

MS-Office administrations, RA databases

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
National
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
3404
Alter
60
Berufserfahrung
29 Jahre und 4 Monate (seit 11/1994)
Projektleitung
28 Jahre

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