Executive, Toxicology

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:
Working independently under the direction of the Deputy Manager
- GBS Global Regulatory Affairs or Drug Information & Risk Management, 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.

**Responsibilities**:
**Primary 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.
- 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.
- Ensures good regulatory compliance.
- Functions as the Subject Matter Expert for toxicological sciences for the global organization.

**Additional Responsibilities**:

- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.

**Job Requirements**:

- Education
- Master of Pharmacy in Pharmacology, M. Pharm,
- Bachelor of Pharmacy, B. Pharm
- 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 years of experience in Toxicology CRO and Pharmaceutical industries.

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.