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

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

• Naturwissenschaft
• Regulatory Affairs25 J.

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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.

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