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References and Network Contakt Ellen Güttler
Deutsche Sprache

About Ellen Güttler
Mai 2013 -
Managing Director at Regulatory Science and Clinical Research GmbH

April 2011 -
Freelancer Regulatory Science and Clinical Research


Freelance Projects - Drug Regulatory Affairs -

• Project at Sanofi Pasteur MSD, Berlin (Nov 2012 until Dez 2015)
Working on Biologics, Maintenance Management, Vaccines. Focus: CMC variations acc. to EU and US regulatory requirements (adoption from US to EU); Compilation of eCTD sections for Module 1-3, Life cycle management and compliance, Labeling management, tracking and follow up of regulatory databases, submission management (organisation of MR/DCP variation submissions among different EU countries).
• Project at BI, Ingelheim (Mar 2016 until Oct 2016) Transfer of 100 MAs (OTC) to another company: Checking of original documentation (800 folders) on relevance for Transfer, development of an archiving system for transport of original documentation.

• Project at Wörwag Pharma, Böblingen (Nov 2016 until Aug 2017) New MAAs and Maintenance Management (incl. CMC) Biofactors and Generics (e.g. Variations acc. to CR (EC) No 1234/2008, Variations and Renewals Non-EU, eCTD management).

• Project at Aristo Pharma GmbH, Berlin (Aug 2017 until July 2018) Maintenance Management original MAs and Generics: CMC-Variations acc. to CR (EC) No 1234/2008 in EU, CMC Module 3 writing, eCTD management; Pharmacovigilance: Case reporting, Quality complaints (2011)

• Project at Daiichi Sankyo Europe GmbH, München (Sept 2018 until Sept 2020) Marketing authorisation applications and Life Cycle Management activities for Eastern Countries, Israel and Afrika.

• Project at BioNTech SE, Mainz (Feb 2021 until Feb 2022): Marketing authorisation applications and Life Cycle Management activities of Covid-19 mRNA vaccine in Asian countries
January 2008 –
April 2011
Manager Drug Regulatory Affairs
MEDA Pharma GmbH & Co.,
Benzstraße 1, 61372 Bad-Homburg

• Responsible for EU-Procedures: DCPs/MRPs:
Project management of a new developmental product (indication Allergy) in order to perform the EU MA-Application (DCP/eCTD)-restructuring of US Dossier to EU requirements; new CTD Module 3
• Compilation of a wwPSUR including CCDS update
• Communication with affiliates from headquarter office (EU and Non EU) / Maintenance
• Coordination of internal and external product development teams also re CMC within different departments and external consultants

December 2006 Scientific Adv. Pharmacovigilance/Oncology

November 2005 – December 2006 Scientific Advisor Regulatory Science
Bristol-Myers Squibb GmbH & Co. KGaA, Sapporobogen 6-8, 80637 München

Regulatory responsibility in terms of national, centralised and MR-procedures for products in HIV, Hep B, and CNS indications, including:

• Correspondence with health authorities/ECs
• Accompanying of MA-Application processes to regulatory approval/ launch (Award 2006)
• Maintenance: CMC-Variations; Renewals (PSURs)
• Communication with EU/US headquarters
• Brand team member/AP&P Approvals/SOPs

September 2002 – November 2005 Regulatory Affairs Coordinator
Coordination of submissions for MA's in HIV and Oncology/Pain indications, Award 2004, incl.: SPCs/PILs (centralised, MRP)

In parallel to current job, October 2004 –
June 2006
Postgraduate Education - degree “Master of Drug Regulatory Affairs” at DGRA and Rheinische Friedrich-Wilhelms-Universität Bonn

Training in regulatory science for MAs national/ international (EU, USA, JPN, RoW):

• Master thesis (1): Scientific Advice (EU, US)
• CMC, Dossier management, Pre-clinical and Clinical Trials, documentation and development
• Pharmaceutical law: NML: AMG, Clinical Trial Directive, ICH, GCP, IND/IMPD (German, EU, US)
• MAA, Maintenance incl. strategic planning

June 2001 – September 2002 Senior CRA - Project Manager
IMFORM GmbH, Birkenweg 14
64295 Darmstadt

Infectious Diseases (pulmonary)
Project Management and monitoring of phase II trials observing the efficacy of a novel antibiotic in patients with pneumonia and bronchitis, esp.:

• Team leading: driving, coaching and constant motivation of an internal team together with external monitors (free lancers)
• Establishing a query tracking system
• Author of final study report

June 2000 –
March 2001

Senior Clinical Research Associate
Chiltern International GmbH, Frankfurt/ Main

Single German representative for survey, initiation and monitoring of a phase II study in indication: HIV: taking care for 13 sites in Germany, according to ICH/AMG including:

• Coaching on the job of CRAs
• Presentation on Investigators meeting


• Project Management Assistance and in house co-
ordination of 20 sites in Germany of a phase III -study observing the impact of an approved drug on anaemia in breast cancer stage IV patients

Project Management

• Communication/ moderation from PM to study team and vice versa
• Actualising study status by preparing table calculation-sheets (Excel)
• Co-ordination / logistics of study supplies
• Survey of study initiation process
• Applications to EC / correspondence

June 1998 –
June 2000
Clinical Research Associate
Nephrology (phase II and III)
Monitoring of 4 centres in The Netherlands and Germany of three clinical trials observing the effects of a novel drug for anaemia in (pre-) dialysis patients according to ICH/GCP.

Advanced monitoring skills

• Presentations at CRA-meetings
• Correspondence with Sponsor-companies
• Initiation visits / Close out visits
• Site staff training (e.g. SAE-reporting)

Routine monitoring, including

• Collection of relevant documents (ICH/ GCP)
• Regulatory and Pharmacovigilance support
• Monitoring of trial/ financial agreements

June 1997 –
May 1998
Clinical Monitor
Wiedey Clinical Research, Frankfurt, FRG

Monitoring of a study Phase II-III :
Eradication vs. a new Proton Pump Inhibitor

• Responsible for 30 sites in Germany

1995 – 1996 Assistant in Technical Data Management
Procter & Gamble, Schwalbach, FRG
via R.H. Hartig OHG

1997 and
Research Assistant
Institute for Molecular Genetics, Gene Technological Safety Research and Consulting, University of Mainz


2007 “Master of Drug Regulatory Affairs”
Certification of Degree at DGRA and Rheinische Friedrich-Wilhelms-Universität Bonn


Certificate: project management and marketing

1988 – 1995 MSc Biology,
University of Mainz, FRG

Molecular Genetics, Immunology, Human Genetics, Zoology

1990 – 1992 German Studies (Teacher’s level):
University of Mainz, FRG

1990 Abroad: educational trip to Northern Ireland

1987 German school final examination (”Abitur”)


  Computer literacy: MS Office: Word / Excel / Powerpoint / Windows XP/ MS Project, Internet
User knowledge in SAS/ ACCESS databases

Driving license:
full, clean


September 2002 – present Regulatory Trainings (1-2 occasions/year)
e.g. Updates on Clinical and Safety requirements, Variations, Renewals, Scientific Advice

October 2006

Introductory pharmacovigilance training

June 1997 – September 2002 Monitor training
Standard Operating Procedures, Declaration of Helsinki, ICH/ GCP, FDA, AMG, medical topics

1996 Course for project management/ marketing
Project dealing with trade relations concerning OTC, presentation of project at IHK Mainz


German mother tongue


French basic
Spanish basic