Je suis totalement bilingue français-anglais, avec la double nationalité américaine et française.
I am completely bilingual American-French, with dual American and French citizenship.
I joined Novexel SA after Pfizer decided to announce the closing of the Global R&D site where i was located in my previous position.
From April 2005 to May 2007, as an Associate Director, I lead the site non-clinical Regulatory Submissions team within Drug Safety R&D in Pfizer Global Research & Development; i'm also a Drug Regulatory Strategy Lead in their Regulatory Submissions department.
Until March 2005, I was working for DuPont de Nemours Europe/Middle East/Africa as a toxicologist specialised in human health risk assessment of chemicals and leader of the French Registration and Regulatory Affairs group. My background is in veterinary medicine with postdoctorate work in toxicology carried out in New Mexico State University and Research
Triangle Park (NC, USA), working with CIIT, a toxicology research
institute. I also successfully completed a previous 4-year management assignment in DuPont, leading a European team & network of professionals in regulatory affairs. I have dual American/French citizenship and grew up as an 'Army brat', moving numerous times to many different places in the USA and Europe (France, Germany, Greece). As a result, I have a strong capacity to adapt to new environments, and also a certain multicultural awareness. I speak American and French fluently, as well as conversational modern Greek, Spanish, and notions of Italian and German. I very much enjoy the European lifestyle and the American corporate culture that I have the privilege to share in my current professional situation, it's a great compromise between what I like to do and what I wish I could do.
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Lorraine Tilbury
Scientific & Medical Writer, Novexel SA
Paris and Tours (Loire Valley) - France
| English | French |
Schools attended |
NMSU (Toxicology (Chemistry/Biology)) |
Ecole Nationale Vétérinaire (CES de Toxicologie et d'AnatomoPathologie des Animaux de Laboratoire) |
Since 2007: Novexel SA |
Scientific and medical Writer
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I contribute to, verify, and finalise all the regulatory documents and publications prepared by Novexel experts (Investigator Brochures, IMPDs, IND overview documents, Clinical Protocols, Clinical Study Reports, etc). I also prepare Novexel's medical communication strategies and plans. | |
Sector: Biotech |
2005 - 2007 : Pfizer Global R&D |
Regulatory submissions lead
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In addition to my Regulatory Strategy responsibilities, I lead a group consisting of 7 direct reports that formatted and published toxicological reports and carried out Quality Control of regulatory documents and submissions. I developed and implemented worldwide regulatory filing strategies for new drug candidates, in close partnership with project teams located in Europe, the United States and Japan. This includes the preparation of regulatory documents such as Investigators Brochures (IBs), Clinical Trials Applications (CTAs), Investigational New Drug (IND) or Common Technical Documents (CTDs) for market authorizations worldwide. I also analyze and validate study reports, to ensure regulatory compliance, and I participate in ‘due diligence’ activities to assess potential in-licensing candidates. | |
Sector: Pharmaceutical |
2003 - 2005 : DuPont de Nemours |
Regulatory Affairs Manager
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In addition to the regulatory toxicology responsabilities I lead the Registration and Regulatory Affairs group for the French business (as ‘Directeur Homologation’ in French). My role was to lead and coordinate crop protection registrations in France and build the registration competency in alignment with the future business direction. | |
Sector: Chemical industries |
1998 - 2005 : DuPont de Nemours |
Regulatory Toxicologist
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Member of the Europe/Middle East/Africa (EMA) Registration and Regulatory Affairs (R&RA) team. After a very successful assignment in management, I returned to this position in order to achieve a better balance between my career and my family of 3 small children. I was responsible for regulatory toxicology matters regarding new and existing crop protection products in Europe, Middle East and Africa, reporting to the Registration and Regulatory Affairs regional leader. I prepared interpretative summaries, conducted modelling exposure assessments, performed risk assessments of crop protection chemicals, and communicated toxicology data to government officials, internal registration specialists, and business functions. I also assessed the impact of evolving trends in toxicology on future regulatory work, and served as a “registration mentor”. | |
Sector: Chemical industries |
1993 - 1997 : DuPont de Nemours |
Registration and Regulatory Affairs Manager, Europe/Middle East/Africa
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Functional leader for the EMA R&RA network, consisting of more than 30 registration personnel based in key countries, with an additional regional group of 12 registration managers/specialists reporting directly to me. My role was to lead and coordinate CPC registrations in Europe, the Middle East, and Africa, and to build the registration competency in alignment with the future business direction. This role included budget accountability for more than 3 MM USD, and the development of R&RA strategies to enable dynamic growth of the crop protection chemical business. My outstanding interpersonal skills, multicultural awareness, excellent teambuilding, communication and negotiation skills, both internally and externally, were key to my success in this position. | |
Sector: Chemical industries |
Hobbies |
Horseback riding windsurfing reading, journal writing choir singing Equitation, randonnée à cheval, chasse a courre Natation, planche à voile Lecture Chant choral Voyage |