Regulatory Toxicologist/Regulatory Affairs Lead

• May 2020 - Present

CEO and Founder

• Apr 2013 - Present

http://www.globalregcom.com Global Regulatory Communications meets your regulatory communication needs worldwide for regulated businesses such as pharmaceuticals, pesticides, chemicals (REACH legislation), cosmetics - via dossier compilations and writing, regulatory project management, understanding and interpreting legislation, regulatory toxicology expertise. http://www.globalregcom.com Global Regulatory Communications meets your regulatory communication needs worldwide for regulated businesses such as pharmaceuticals, pesticides, chemicals (REACH legislation), cosmetics - via dossier compilations and writing, regulatory project management, understanding and interpreting legislation, regulatory toxicology expertise.

Founder

• Mar 2013 - Present

Jumpstart your projects with the power of the Horse! Certified Eponaquest Instructor. "Way more than coaching" (TM) Jumpstart your projects with the power of the Horse! Certified Eponaquest Instructor. "Way more than coaching" (TM)

Regulatory Expert

• Feb 2016 - Sep 2020

Regulatory Expert & Toxicologist. Regulatory Expert & Toxicologist.

VP Mentoring

• May 2014 - May 2020

The VP Mentoring in coordination with the Mentoring Steering Committee develops the Federation’s overall strategy for developing and supporting mentoring activities across the globe. The VP Mentoring in coordination with the Mentoring Steering Committee develops the Federation’s overall strategy for developing and supporting mentoring activities across the globe.

South EU Regulatory Leader, Nufarm S.A.S.

• Jun 2012 - Mar 2013

Newly created role to lead the South EU regulatory network, so that Southern zone regulatory strategies are developed and implemented creatively and efficiently in order to maintain and expand the business in Southern Europe.

EU Regulatory Affairs manager

• Mar 2009 - Mar 2013

In this newly created role, Lorraine will generate a Pan-European approach to deliver a regulatory affairs strategy that ensures the best possible market access of the new and existing Nufarm product portfolio. Lorraine will be the functional leader of the country regulatory teams in order to improve country regulatory strategies in Europe in line with the Nufarm business strategy.

Regulatory Affairs Leader, France, & EU project leader

• Mar 2009 - Nov 2010

Managed FR & EU project-specific budget, kept regulatory projects on track, resolved regulatory project technical difficulties, built relationships with officials.

EU R&D Technical Director

• Jul 2008 - Mar 2009

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. 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.

Associate Director, Regulatory Submissions Lead

• Apr 2005 - Jul 2008

- 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.

Associate Research Fellow, Development & Regulatory Strategy,

• Feb 2005 - Jul 2006

- 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.

Scientific & Medical Writer

• May 2007 - Apr 2008

- 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. - 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.

Registration & Regulatory Affairs Manager, France

• Sep 2003 - Feb 2005

- 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

Regulatory Toxicologist, Europe, Middle East, Africa (EMA)

• Jan 1998 - Feb 2005

• 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”. Show less

Registration and Regulatory Affairs Manager, EMA

• Nov 1993 - Dec 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. • 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. Show less

Regulatory Toxicologist, Europe, Middle East, Africa (EMA)

• Sep 1990 - Dec 1993

• 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. Show less