Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.


Job Summary

Working independently under the direction of the Head – Global Medical Affairs, GBS, brings toxicological expertise in the Risk Assessment process to support risk assessment and Health Hazard Assessment (HHA) activities for the business as required. Major stakeholders are Research and Development, Quality Assurance, Safety Health & Environment and others

Job Responsibilities
  • Conducts Health Hazard Assessments in a timely manner upon request with a high level of autonomy.
  • Actively conducts risk assessment activities for a variety of situations from a toxicological perspective when needed.
  • Establishes acceptable and/or tolerable daily intakes for substances in question through review or calculations.  
  • Identifies No Observed Effect Levels (NOEL) and No Observed Adverse Effect Levels (NOAEL), Lethal Dose 50 (LD50) etc.
  • Generates reports with a toxicological conclusion for the assessment in question based on the literature, the circumstances and the results of studies, if undertaken, based on sound toxicological science.
  • Regular interactions with Regulators such as Health Canada, FDA, and other competent Authorities in the EU and Australia to address toxicological issues in New Product Submissions and Marketed Products.
  • Supports Safety, Health and Environment with toxicological assessments when requested.
  • Supports business units in GRDQ such as Global Project Management, Quality Assurance, Formulation Development, Analytical Operations etc. bringing toxicological expertise to bear.
Job Requirements
  • Education
    • Master of Veterinary Science, M. Pharm,
    • Certification- Diplomat American Board of Toxicology (preferred)
  • Knowledge, Skills and Abilities
    • General and Regulatory toxicology, Risk characterization, safety assessment, Consumer products, Good Laboratory Practice, as a toxicologist in the area of drug development.
    • Good knowledge and skill in toxicological testing procedures for pesticides, new chemical entities, IND requirements.
    • Good knowledge and skill in risk assessment procedures for Medical products/Medical devices.
  • Experience
    • >5-7 years of experience either in Toxicology CRO, Pharmaceutical industries, Consumer safety assessment.



At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.


from Apotex – Scientific & Regulatory Affairs https://ift.tt/2Q59bPD

About Apotex

Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 6,500 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies with 5,800 employees now occupy over 3 million square feet in Montreal, Richmond Hill, Toronto, Etobicoke, Mississauga, Brantford, Windsor, Winnipeg, London, Calgary and Vancouver. Apotex produces more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 89 million prescriptions a year – the largest amount of any pharmaceutical company in this country.

Today, Apotex is a necessary and trusted member of Canada’s healthcare community. The company’s pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe. Export markets represent an ever growing portion of the total sales. Apotex has also established a presence through subsidiaries, joint ventures or licensing agreements in Australia, Belgium, Czech Republic, Mexico, Netherlands, New Zealand, Poland, Turkey, and the in, to name just a few. Healthcare professionals around the world rely on Apotex for quality and value.

Although the company’s own business is developing and manufacturing generic pharmaceuticals, the success of Apotex has enabled it to diversify into a number of other health-related areas. The Apotex Pharmaceutical Group of Companies also researches, develops, manufactures and distributes fine chemicals, non-prescription and private label medicines, and disposable plastics for medical use.

The worldwide sales of the Apotex Group of companies exceed $1 billion (Canadian $) per year.