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.
This position is responsible for executing critical incident escalations and market action programs. 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.
Job ResponsibilitiesDevelop 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 Q&C GFMR w.r.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 Q&C GFMR w.r.t. the Recall system to ensure timely and complete product recalls are effectively performed.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.Job RequirementsEducationB.Sc. in Chemistry, Biochemistry or a related scienceKnowledge, Skills and AbilitiesDemonstrated & 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.Flexibility in response to a changing and evolving environment, deadline oriented.Exhibited business acumen in understanding cross-functional processes, requirements, and relevant information flows, and translating gaps into solutions.Demonstrated strategic, process-driven, analytical, and critical thinking.Proven experiences in holding people accountable, developing cross-functional teams, and facilitating decision-making processes.Knowledge of SAP, TrackWise, excel, word, other Microsoft office programs.ExperienceMinimum 8-10 years of experience in the GMP Regulated industry.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.
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