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Summary

i have obtained over 25 years of professional experience in Toxicology, both in industry (Pharmaceuticals, chemicals) and a regulatory agency (Health canada ). since early 2006, i have been Director of nonclinical Toxicology & pharmacology, global Regulatory Affairs in gsk Vaccines, based in wavre, belgium . this role has provided me with extensive experience in the Planning and placement of glp toxicity studies, prepartion and review of the non-Clinical Toxicology sections of regulatory submissions (ind, cta, bla, maa etc), interactions with regulatory agencies worldwide, participation in internal safety monitoring boards, and project teams. my previous positions have provided me with extensive experience in Health hazard and Risk Assessment for chemicals and pesticides, industry association activities related to Toxicology and product safety, occupational Toxicology, hazard Communication and hazard classification.

my current employment contract is a local belgian contract.  i have a “titre de sejour” and national number in belgium, so i do not require a work permit here, although i am a canadian citizen. i also own a home in spain, and i am seeking a position that will allow me to work from a "home office" there as well as in belgium.  in the medium term, i plan to move to my home in spain and hope to continue work from a "home office" there. please feel free to contact me should you require any further information about my background. 

 

best regards,

 

lawrence segal, phd, ert

brussels, belgium 

email: lm_segal@yahoo.com

 

Experiences

Current Experience

  • Director, Nonclinical Toxicology & Pharmacology, Global Regulatory Affairs


    Since April 2006
    the key areas of responsibility include: • provision of Expert advice concerning the Preclinical Safety of gsk biologicals products, including vaccine Formulations, adjuvant systems, residuals and contaminants; • preparation, coordination and approval of the nonclinical Toxicology and pharmacology sections of all dossiers for worldwide regulatory agency submission; • manage a section of 4 professionals (phd level toxicologists and pharmacologists) and external consultants • interface with cros, review and approve study protocols and reports for Toxicology studies; • provide Toxicology/pharmacology input for issues under review by gsk biologicals vaccine safety monitoring board and/or Toxicology working group; • participate as ra Member of gsk biologicals reach task force; • maintain a thorough understanding of Toxicology Testing requirements for Vaccines worldwide; • liaise with toxicologists, physicians, scientists, or managers within gsk, other vaccine producers, regulatory agencies, or international organisations in the area of Toxicology/Preclinical Safety of Vaccines or biologicals The key areas of responsibility include: • Provision of expert advice concerning the preclinical safety of GSK Biologicals products, including vaccine formulations, adjuvant systems, residuals and contaminants; • Preparation, coordination and approval of the nonclinical toxicology and pharmacology sections of all dossiers for worldwide regulatory agency submission; • Manage a section of 4 professionals (PhD level toxicologists and pharmacologists) and external consultants • Interface with CROs, review and approve study protocols and reports for toxicology studies; • Provide toxicology/pharmacology input for issues under review by GSK Biologicals Vaccine Safety Monitoring Board and/or Toxicology Working Group; • Participate as RA member of GSK Biologicals REACh Task Force; • Maintain a thorough understanding of toxicology testing requirements for vaccines worldwide; • Liaise with toxicologists, physicians, scientists, or managers within GSK, other vaccine producers, regulatory agencies, or international organisations in the area of toxicology/preclinical safety of vaccines or biologicals

Past Experience

  • Global Toxicology & Regulatory Specialist

    September 2004 --- March 2006
    • acted as focal point for activities related to the eu reach regulations; • maintained a thorough understanding of the Toxicology/ecotoxicology requirements under the eu reach programme, and ensure they are addressed proactively; • provided Expert advice in Toxicology, hazard classification, Risk Assessment and product safety regulations to the business within the european, americas and asia/pacific regions; • represented the business on industry associations dealing with ehs/Toxicology issues on a global basis; • liaised with toxicologists, chemists, and industrial hygienists, other chemical companies, regulatory agencies, or international organisations having responsibility in the area of Toxicology, occupational Health, hazard Communication or product stewardship; • searched for and critically evaluate toxicological and Clinical data including: acute toxicity, dermal/ocular irritancy, dermal/Respiratory sensitisation, In Vitro and In Vivo mutagenicity, developmental and reproductive toxicity, oncogenicity, and chronic toxicity for products or raw materials; • acted as point of contact between the business and Testing laboratories, reviewed study protocols, monitored study progress, and assessed regulatory significance of study results; • maintained and expand knowledge of pertinent Health & safety legislation and standards in europe, asia, the usa and canada; • reviewed, established and revised occupational exposure limits as a Member of the workplace environmental exposure limit (weel) committee of the american industrial hygiene association

  • Senior Toxicologist/Team Leader, Hazard Assessment

    April 2000 --- September 2004
    • provided Expert advice in Toxicology, Risk Assessment and product safety to the huntsman polyurethanes, performance chemicals and petrochemicals businesses within the european and asia/pacific regions; • liaised with toxicologists, chemists, and industrial hygienists within huntsman, other chemical companies, industry associations, regulatory agencies, or international organisations having responsibility in the area of Toxicology, occupational Health, hazard Communication or product stewardship; • searched for and critically evaluated toxicological and Clinical data including: acute toxicity, dermal/ocular irritancy, dermal/Respiratory sensitisation, In Vitro and In Vivo mutagenicity, developmental and reproductive toxicity, oncogenicity, and chronic toxicity for raw materials or formulated products; • supervised a junior toxicologist involved hazard assessment, literature search, and the preparation of Toxicology/ecotoxicology input to data sheets and/or labels for huntsman products in europe and asia/pacific; • acted as point of contact between huntsman and Testing laboratories, review study protocols, monitored study progress, and assessed regulatory significance of study results; • participated as a Member of a global team composed of it and ehs professionals engaged in the implementation of a new safety document authoring system, and acted as the lead ehs Member for the european/asian region; • maintained and expanded knowledge of pertinent Health & safety legislation and standards in europe, asia, the usa and canada; • reviewed, established and revised occupational exposure limits as a Member of the workplace environmental exposure limit (weel) committee of the american industrial hygiene association,

  • Senior Toxicologist and Head, WHMIS Evaluation Section

    January 1990 --- March 2000
    • directed a section consisting of 7 professionals and 1 support staff. • developed, revised and implemented service standards and review procedures for Health & safety data on hazardous industrial chemicals subject to whmis. • provided Expert advice in Toxicology to the section, division, bureau and branch. • provided advice on the interpretation of, and proposals for amendments to, whmis legislation. • performed management functions such as staffing, performance appraisal, supervision and review of work, budgetary control, operational and work Planning, and acting as division chief when required. • maintained a knowledge of pertinent occupational Health & safety legislation and standards in canada and internationally. • established and maintained links with provincial, federal and international agencies in technical areas related to occupational Health and safety or whmis. • reviewed, established and revised occupational exposure limits as a Member of the workplace environmental exposure limit (weel) committee of the american industrial hygiene association (aiha).

  • Toxicologist, Pesticides Div.

    May 1988 --- January 1990
    principal duties of this position included: • review of toxicological data submitted by industry and the evaluation of Health hazards posed by pesticides in the work place and environment; • the preparation of critical reviews and regulatory documents on pest control products; • liaison with industry and Agriculture canada on matters related to the toxicological evaluation and registration of pesticides; • participation in Research projects in in-vitro Toxicology; • provision of Expert advice on Toxicology and environmental Health issues

Knowledge

LinkedIn Assessment :
Regulatory ToxicologyVaccine nonclinical safetyHealth risk assessmentRegulatory affairsOccupational HealthR&DPharmaceutical IndustryGood Laboratory Practice (GLP)LifesciencesBiotechnologyFDAToxicologySafetyVaccinesRisk AssessmentIn VitroIND

Education

  • PhD in Toxicology from University of Saskatchewan in 1987
  • MSc, BSc(Hons) in Biology from Carleton University in 1980
  • in from Merivale HS in 0000
  • in from VUB Spanish class in 0000

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes

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