Become a key player in compliance management at Apotex as a Manager of Regulatory Compliance Operations. Direct oversight and support during regulatory inspections forms the bedrock of this role.
This managerial role requires you to engage with regulators, assess and analyze compliance trends, and maintain relationships vital to ensuring product quality and conformity. You will drive process improvements and regulatory communications, providing insights that influence organizational standards within the pharmaceutical sector.
Key Responsibilities:
• Interact with external regulators regarding compliance issues
• Evaluate and manage product defect notifications
• Develop SOPs and business processes to uphold quality standards
• Support audit preparations and represent Apotex in inspections
• Provide critical insights on regulatory changes impacting products
Requirements:
• B.Sc. in Chemistry or Biochemistry
• 8-10 years in GMP regulated environments
• Pr...