
Regulatory Affairs Leader, France, & EU project leader at Nufarm
Le Mans Area, France

Regulatory Affairs Leader, France, & EU project leader at Nufarm
Le Mans Area, France
Dual American-French national (English mother tongue) trilingual (American/French/Spanish) American Board-Certified regulatory toxicologist (degree in Vet Med) with 15 years experience in pesticide regulatory affairs, including international managerial experience. Also interested in pharmaceutical and chemical regulatory affairs (3 years experience in pharmaceutical regulatory affairs, primarily non-clinically related), as well as experience in medical writing and regulatory dossier preparation. Interested in a challenging career in regulatory affairs in Europe (ideally France) with or without managerial responsibilities.
Regulatory Toxicology, Chemical Regulatory Affairs, REACH, Pesticide Regulatory Affairs, pharmaceutical regulatory affairs, Non-clinical research, Medical Writing, Scientific writing, toxicology, nonclinical, preclinical, pre-clinical, Regulatory affairs, IND, IMPD, NDA, EMEA, FDA
(Public Company; Chemicals industry)
March 2009 — Present (5 months)
(Privately Held; Chemicals industry)
July 2008 — March 2009 (9 months)
On temporary assignment with Arysta as part of the Pfizer outplacement process, Lorraine is managing the EU R&D budget, keeping regulatory projects on track, resolving regulatory project technical difficulties, and driving change throughout the EU R&D organisation.
(Public Company; 10,001 or more employees; PFE; Pharmaceuticals industry)
April 2005 — July 2008 (3 years 4 months)
- Lead a group consisting of 7 direct reports that formatted and published toxicological reports
- carried out Quality Control of non-clinical regulatory documents and submissions.
- The R&D site where Lorraine is located is closing following a re-organization of Pfizer Global R&D.
(Privately Held; 11-50 employees; Biotechnology industry)
May 2007 — April 2008 (1 year)
- contributed to, verified, and finalized clinical study reports, protocols, and all the regulatory documents and publications prepared by Novexel experts for submissions in the USA and in Europe.
- compiled, wrote and submitted Investigational New Drug dossiers (INDs) to the FDA in the USA.
- prepared Novexel's medical communication strategies and Standard Operating Procedures (SOPs) related to Document Management.
(Public Company; 10,001 or more employees; PFE; Pharmaceuticals industry)
February 2005 — July 2006 (1 year 6 months)
- Prepared interpretative summaries and conducted safety assessments of compounds in development.
- Contributed to regulatory strategy via contributions through external professional networks and interactions with the authorities and academic experts.
(Public Company; 10,001 or more employees; DD; Chemicals industry)
September 2003 — February 2005 (1 year 6 months)
- lead the Registration and Regulatory Affairs group for the French business (Directeur Homologation).
- coordinated crop protection registrations in France and
- built the registration competency in alignment with the business
(Public Company; 10,001 or more employees; DD; Chemicals industry)
January 1998 — February 2005 (7 years 2 months)
• Board-certified by the American Board of Toxicology since November 2000. Member of the EMA Registration and Regulatory Affairs (R&RA) team.
• Responsible for regulatory toxicology matters regarding new and existing crop protection products in Europe, Middle East and Africa
• Prepared interpretative summaries, conducted modeling exposure assessments, performed risk assessments of crop protection chemicals, and presented company’s intrepretation of toxicology data to government officials, internal registration specialists, and business functions.
• Assessed the impact of evolving trends in toxicology on future regulatory work, and served as a “registration mentor”.
(Public Company; 10,001 or more employees; DD; Chemicals industry)
November 1993 — December 1997 (4 years 2 months)
• 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.
• Lead and coordinated crop protection chemical (CPC) registrations in Europe, the Middle East, and Africa,
• Built the registration competency in alignment with the future business direction.
• Budget accountability for more than 3 MM USD
• Development of R&RA strategies to enable dynamic CPC growth. Lorraine’s outstanding interpersonal skills, multicultural awareness, excellent teambuilding, communication and negotiation skills, both internally and externally, were key to her success in this position.
(Public Company; 10,001 or more employees; DD; Chemicals industry)
September 1990 — December 1993 (3 years 4 months)
• Responsible for regulatory toxicology matters regarding new and existing crop protection products in Europe, Middle East and Africa
• Identified studies needed to support EMA product registrations, ensured their timely completion
• Prepared interpretative summaries, conducted modeling exposure assessments, performed risk assessments of crop protection chemicals
• Presented company’s intrepretation of toxicology data to government officials, internal registration specialists, and business functions.
(Biotechnology industry)
1989 — 1990 (1 year)
M.Sc. , Chemistry/Biology (Toxicology) , 1988 — 1990
Completed an internship at Chemical Industry Institute of Toxicology (CIIT), now called The Hamner Institutes for Health Sciences, as part of M.Sc. thesis.
1980 — 1985
Baccalaureat , Science , 1972 — 1978
connecting with others via IT, regulatory toxicology, horses, horseback riding, veterinary medicine, choir singing, writing, mensa, chasse a courre
European Professional Women's Network (PWN),
Society of Toxicology, Frenchie Productions, American Board of Toxicology, Vautrait "Les Echos d'Amboise"