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Lorraine TILBURY

PARIS AND TOURS (LOIRE VALLEY)

En résumé

Je suis totalement bilingue français-anglais, avec la double nationalité américaine et française.
References and a detailled profile are also on LinkedIn at http://www.linkedin.com/in/lorrainetilbury

Depuis mars 2013 Lorraine dirige son entreprise de consultance en affaires réglementaires: Global Regulatory Communications, qui propose des solutions à tous vos besoins en communications réglementaires dans le domaine de la chimie, l'agrochimie, la pharmacie et la cosmétique.

In March 2009, Lorraine joined Nufarm SAS, (http://www.nufarm.com ) leading their France Regulatory Affairs group and also leading some key EU regulatory projects.

From July 2008 - February 2009, in a temporary assignment, Lorraine successfully drove change throughout Arysta Lifescience's EU regulatory group, managing the regulatory R&D budget, ensuring that key regulatory projects were on track, and began implementing organisational changes through brainstorming with the EU regulatory team and its leadership.

From May 2007 to April 2008, Lorraine was a Scientific and Medical Writer for Novexel (http://www.novexel.com ), a new pharmaceutical company that intends to become a leader in the expedited research and development of novel class anti-infectives for the treatment of severe and difficult to treat bacterial and fungal infections. She joined Novexel after Pfizer Global R&D announced their plan to close the Amboise, France site in Jan07.

In April 2005, Lorraine was part of Pfizer Global Research & Development as an Associate Research Fellow in their Regulatory Submissions department. In July 2006, she became an Associate Director with Pfizer R&D, leading their local Regulatory Submissions group in Amboise.

Until March 2005, Lorraine worked 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. Her 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.

She also successfully completed a previous 4-year management assignment in DuPont, leading a European team & network of professionals in regulatory affairs with budget responsibility for several million USD.

Lorraine has 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, she has a strong capacity to adapt to new environments, and also a certain multicultural awareness. Lorraine speaks American and French fluently, as well as conversational modern Greek, Spanish, and notions of Italian and German. She very much enjoys the European lifestyle and the American corporate culture that she has the privilege to share in her current professional situation.

Mes compétences :
Anglais
Bilingual
Développement
English
Langue maternelle
Médical
Pesticides
Protection des cultures
Recherche
Recherche et Développement
Research
Research and Development
USA
Vétérinaire
Writer

Entreprises

  • Global Regulatory Communications - Leader en Affaires Réglementaires et Experte Toxicologue

    2013 - maintenant Lorraine apporte des solutions à tous vos besoins de communication réglementaire dans les domaines de la chimie, l'agrochimie, la pharmaceutique et la cosmétique.

  • Nufarm S.A.S. - France Regulatory Affairs Leader/EU Regulatory Project Leader

    2009 - 2013 Manage FR & EU project-specific budgets, keep regulatory projects on track, resolve regulatory project technical difficulties, build relationships with officials in France and in the EU.

  • Arysta Lifescience - R&D Technical Director

    NOGUERES 2008 - 2009 On temporary assignment with Arysta as part of the Pfizer outplacement process, Lorraine managed the EU R&D budget, kept regulatory projects on track, resolved regulatory project technical difficulties, and drove change throughout the EU R&D organisation.

  • Novexel SA - Scientific and Medical Writer

    2007 - 2008 I contribute to, verify, and finalise all the regulatory documents and publications prepared by Novexel experts. I also prepare Novexel's medical communication strategies and plans.

  • Pfizer Global R&D - Directeur Associé, Soumissions Réglementaires

    Paris 2005 - 2007 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.

  • Pfizer Global R&D - Conseiller Scientifique

    Paris 2005 - 2007 I develop and implement 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.

  • DuPont de Nemours - Registration & Regulatory Affairs Manager, France

    2003 - 2005 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.

  • DuPont de Nemours - Toxicologue Reglementaire

    1998 - 2005 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”.

  • DuPont de Nemours - Registration and Regulatory Affairs Manager, EMA

    1993 - 1997 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.

  • DuPont de Nemours - Regulatory Toxicologist, Europe, Middle East, Africa

    1990 - 1993 A member of the EMA Registration and Regulatory Affairs team, I was responsible for regulatory toxicology matters regarding new and existing crop protection products in Europe, Middle East and Africa, reporting to the Regional Registration and Regulatory Affairs Manager. I identified studies needed to support EMA product registrations, ensured their timely completion, 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.

  • CIIT, Research Triangle Park, NC - Post-doctoral assignment

    1989 - 1990 I designed and conducted a 90-day inhalation study in rats and mice, exposing them to vapors of unleaded gasoline. The results of this study were the basis for an Interdisciplinary (Chemistry/Biology) Master of Science thesis defended in July 1990 at New Mexico State University (Grade Point Average (GPA) = 4.0, the highest grade possible). I also participated in several ongoing projects studying cell proliferation and carcinogenesis. Related publication references (in Carcinogenesis, J Tox Env Health) available on request.

Formations

  • New Mexico State University Department of Animal and Range Sciences (Las Cruces)

    Las Cruces 1988 - 1990 Toxicology (interdisciplinary Chemistry/Biology)

    Toxicology (Chemistry/Biology) - Post-doctoral assignment at CIIT, Research Triangle Park, North Carolina, USA, during the same period.

  • Ecole Nationale Vétérinaire

    Toulouse 1980 - 1984 Immunologie de FeLV (1985)

    CES de Toxicologie et d'AnatomoPathologie des Animaux de Laboratoire

Réseau

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