Manager, Corporate Compliance

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
Interface with regulators and liaise with stakeholders across the business to support quality and compliance team. This position provides compliance oversight, support during regulatory inspection, review and develop regulatory authority communications globally and perform industry trend analysis, as required.
Develop and maintain effective relationships with external Regulatory Agencies and business partners as well as internal Apotex stakeholders in order to ensure timely notifications and resolutions to discovered potential pre and post distribution product defects.
Responsible for interacting with regulators, ministries of health, global affiliates and customers on compliance related matters as required.
Act as a compliance contact for regulatory queries and issues from partners and affiliates.
Evaluate current regulatory trends and reporting on risks to Apotex.
Support Associate Director, Corporate Systems & Compliance w.
T. the Regulatory Notification system to ensure Health Agencies are notified within required time frames of potential defects for distributed products, and support ad hoc communication with Health Authorities.
Support Associate Director, Corporate Systems & Compliance w.
Develop and implement appropriate business processes and controls including SOPs, in order to maintain effective quality standards.
Provide preparatory support for post-market inspections and audits by Regulatory Authorities as well as third parties as required.
Represent Corporate Quality & Compliance during site and functional area inspections by Regulatory Agencies and external customers.
Provide recommendations to senior management that have direct impact on commercial products.
Provide information/insight on regulatory requirements and stay abreast of changes in regulatory environment/trends.
Provide technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance.
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.
Demonstrated & thorough knowledge of the GMPs relative to Health Canada, FDA and other global pharmaceutical regulations.
Clear and concise written and verbal English communicationStrong organizational, interpersonal and communication skills.
Ability to work under pressure and effectively in an international and multicultural matrix organization.
Knowledge of SAP, TrackWise, excel, word, other Microsoft office programs

We offer
accommodation for applicants with disabilities as part of its recruitment process. The hiring range for this position is $96,551.00
- $160,918.00 CAD per year. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development. Apotex will use artificial intelligence to screen, select and/or assess your application for this job.