About Ellen Güttler

Mai 2013 - present

Managing Director at Regulatory Science and Clinical Research GmbH

April 2011 - 2013

Freelancer Regulatory Science and Clinical Research

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CAREER HISTORY

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 Virology 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 Oncology • 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 Gastroenterology 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 1993-1994	Research Assistant Institute for Molecular Genetics, Gene Technological Safety Research and Consulting, University of Mainz

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QUALIFICATIONS

2007	“Master of Drug Regulatory Affairs” Certification of Degree at DGRA and Rheinische Friedrich-Wilhelms-Universität Bonn
1996	Certificate: project management and marketing
1988 – 1995	MSc Biology, University of Mainz, FRG subjects: 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”)

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ADDITIONAL SKILLS / INFORMATION

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

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TRAINING

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

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LANGUAGES

German	mother tongue
English	excellent
French	basic
Spanish	basic