Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the Country. We have an incredible team of bright, passionate, and committed individuals, who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our growing team.
We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds.
We’d love to hear how you could contribute to the Team!
The Supervisor, CMC QA is responsible for ensuring product submissions to domestic and international regulatory agencies are reviewed by Quality and meet the global and regional standards, resulting in successful approval of products in the shortest possible time.
• Oversee the review of regulatory submissions confirming adherence to regulatory requirements and consistency of the overall message across documents within a dossier.
• Provide feedback on the content and format of submission documents to ensure the data is accurately and appropriately represented.
• Review deficiency responses to ensure all regulatory queries are appropriately addressed by the functional area with adequate supporting documentation.
In conjunction with RA, ensure areas identified as a result of the trending of deficiencies are utilized to promote opportunities for continuous improvement.
• Identify potential issues that may impact timelines and quality of regulatory submissions.
• Confirm adherence to established submission requirements, regulations and guidelines.
• Recruit, train and effectively manage the ongoing performance of employees.
• Works as a member of a team to achieve all outcomes.
• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence
• Performs all work in accordance with all established regulatory and compliance and safety requirements
• All other duties as assigned.
• B.Sc in Chemistry, Biochemistry or a related science.
• Minimum of 6 years of experience in the pharmaceutical industry.
• Knowledge of dossier development and formatting requirements.
• Knowledge of ANDA submission requirements including eCTD preparation.
• Knowledge of FDA, TPD and EMA regulatory requirements.
• Knowledge of Electronic Document Management Systems.